Implants

Journal of Rehabilitation Research and Development
Rehabilitation R & D Progress Reports 1990
XI. Orthopedic Implants
A. General
B. Hip
C. Knee
XI . Ortht: ,dic
For additional information on topics related to this category see the following Progress Reports:
[74], [334], [335]
A. General
[353] Percutaneous Prosthetic Limb Attachment
Edmund B. Weis, Jr., MD

Jerry L . Pettis Memorial Veterans Hospital, Loma Linda, CA 92357
Sponsor : VA Rehabilitation Research and Development Service (Project #A487-RA)
Purpose—This project was initiated in order to develop previous experience. The animals are healthier, they bear
a method for the attachment of prosthetic limbs to veteran weight more readily, there is less drainage from the
amputees without the necessity of fitting the anatomy of amputation site, fractures heal, and preliminary histo-
the residual stump and incurring the inherent functional logic data reveal new bone in close approximation to the
and cost limitations of current prosthetic practices. implant . There is no apparent osteomyelitis at 2 months
Utilization of residual muscle capability through a (previously readily apparent) and the skin appears to
percutaneous implant is an ultimate goal. grow tightly around the stem of the implant.
A sheep model was chosen for initial investigations
because of prior work in Spanish goats and because of the Methodology—The sheep were acclimatized to the facil-
extensive use of sheep for bone-healing research. ity for 72 hours prior to surgery. Food was withheld for
48 hours and water for 24 hours . Preoperative sedation
Progress—An initial conception of the requirements of a was with ketamine 1 .5 g intramuscular . Induction for
transitional zone from internal to external milieu in order intubation was accomplished with 500 mg of intravenous,
to eliminate infection led to the development of microvas- short-acting barbiturate and the anesthetic agent was
cular techniques for free vascularized transplant of small Fluothane 1 .5-2 .5% with 4-5 liters of oxygen.
bowel, omentum, or parietal peritoneum to the site of a After routine clipping, without shaving, and skin
midtibial amputation . A four-fluted, self-tapping, stain- preparation with iodine, tibial amputation at the isthmus
less steel intramedullary device with a percutaneous was accomplished by a guillotine technique at a level
pylon for prosthetic attachment was designed and distal to the final site . The periosteum was reflected from
implanted with transplant of tissue with the potential for the distal shaft before amputation of the bone at the
reducing infection . This led to a classical osteomyelitis isthmus so that it could be reflected over the cut end of
with extrusion of the implant and failure in 25 cases. the bone into a recess in the implant.
The implant was revised to a flat broach to preserve A number of 316 L stainless steel implant broach
the endosteal blood supply and while the periosteal sizes from 8 to 13 mm were precoated with hydroxylapa-
reaction and osteomyelitis developed more slowly and to tite by a plasma spray technique and sterilized with ethyl-
a lesser extent in five cases, the outcome was, qualita- ene oxide . The maximum diameter of the tibia at the
tively, the same. amputation site was measured and the next size larger
A review of the literature regarding mandibular implant was driven into the intramedullary canal without
implants led to exploration of the use of hydroxylapatite preliminary preparation.
coating of the implant (without free vascularized trans- Tendons were resected at the amputation level and
plants to establish a baseline of bone and tissue reaction). the skin was closed tightly around the stem of the implant
The initial results are qualitatively different from any in contact with the hydroxylapatite coating . A simple
278
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Orthopedic Implants
pylon prosthesis was friction-coupled to the stem of the of the implant in the endosteal canal and ground section
implant . Aminoglycoside and cephalosporin were of the implant plus bone revealed very close approxima-
injected intramuscular at the end of the procedure and the tion of new bone to coating . There was no evidence
animals were placed in a sling for 3 weeks. of infection.
Results—Three of five animals were walking with some Future Plans/Implications—The long-term history of
weightbearing at 60 days . One animal has broken the these implants must still be evaluated, the prosthesis must
prosthesis three times. be revised to tolerate the increased use imposed by a suc-
One animal fractured the distal tibia in the sling and cessful interface, and the possibility of attachment of the
did not heal. residual muscles and tendons to the prosthesis, through
One animal broke the implant at 5 weeks and was the implant, must be investigated.
necropsied . There was firm fixation of the proximal stem
[354] Fracture Healing and Bone Remodeling in Plated Long-Bones
Gary S. Beaupre, PhD ; Dennis R. Carter, PhD ; John Csongradi, MD

Rehabilitation Research and Development Center, VA Medical Center, Palo Alto, CA 94304
Sponsor : VA Rehabilitation Research and Development Service (Project #A294-2RA)
Purpose—The objectives of this study are to develop radius. The use of unicortical end screws results in a
models of the fracture-healing process for both conserva- plated bone construct that is 40% stronger in the
tively treated and internally plated longbone fractures. bending-open loading mode, and 10% weaker in the
bending-closed loading mode.
Methodology—Both mathematical and experimental
models of fracture healing are used to study the fracture Future Plans/Implications—Future plans include the
healing process . The mathematical models utilize the use of the strain gauge based screwdriver in surgery
finite element technique . Models of conservatively treated to compare insertion and removal torques of plated
long-bone fractures and plated long-bone fractures have forearm fractures . It is anticipated that low values of
been developed . An osteogenic index is used to predict removal torque will indicate that stress shielding is
the regions of a fracture callus which will ossify first. minimal and the risk of refracture will be low. The use
Laboratory models will be used to assess the efficacy of an incremental remodeling program will allow the
of using shortened screws at the outer screw locations prediction of changes in the density distribution caused
compared with using full-length screws for plated frac- by plate fixation.
tures. A strain gauge based torque-measuring screwdriver
has been designed to monitor the insertion and removal
Recent Publications Resulting from This Research
torque of the screws which attach the fixation plate to
A Bone Surface Area Controlled Time-Dependent Theory for
the bone.
Remodeling (Abstract) . Beaupre GS et al ., Transactions of the
Orthopedic Research Society, 14 :311, 1989.
Results—Finite element models of plated long-bones Fracture Healing Patterns Calculated from Stress Analyses of
show that slippage between the plate and the bone influ- Bone Loading Histories (Abstract) . Blenman PR, Carter DR,
Beaupre GS, Transactions of the Orthopedic Research Society,
ences to a great extent the amount of stress shielding. 14 :469, 1989.
Plate slippage is a direct function of screw tightness . A The Role of Mechanical Loading in the Progressive Ossification of
time-dependent, incremental remodeling program has a Fracture Callus. Blenman PR, Carter DR, Beaupre GS,
Orthop Res 7:398407, 1989.
been developed to predict the changes in density distribu- An Approach for Time-Dependent Bone Modeling and
tion caused by the implantation of orthopedic implants. Remodeling—Application : A Preliminary Remodeling
Preliminary models of nonplated long-bones subjected to Simulation . Beaupre GS, Orr TE, Carter DR, J Orthop Res
bending, axial, and torsional loads have been analyzed. 8 :662-670, 1990.
An Approach for Time-Dependent Bone Modeling and
In the experimental phase of the study, plates have Remodeling—Theoretical Development . Beaupre GS, Orr TE,
been applied to phenolic tubes modeling the human Carter DR, J Orthop Res 8 :651-661, 1990.
280
Mechanical Stress Histories and Connective Tissue Differentiation Numerical Methods for Emulating Stress-Induced Remodeling in
(Abstract) . Carter DR et al ., First World Congress of Bio- the Femur (Abstract) . Beaupre GS, Orr TE, Carter DR, First
mechanics, II :80, 1990. World Congress of Biomechanics, II :200, 1990.
[355] Bone Ingrowth and Remodeling with Porous Coated Implants
Dennis R . Carter, PhD; Gary S. Beaupre, PhD ; T.E. Orr, PhD ; D.J. Schurman, MD ; M . Wong, PhD
PurposeThe purpose of this work is to formulate a The proximal tibia and femur models will then be
comprehensive theory consistent with many features of altered to represent the initial implantation of various
skeletal growth and development, maintenance, regenera- uncemented porous coated components . A thin layer of
tion, and degeneration . The results of our previous inves- pluripotential tissue will be represented at the bone/
tigations indicate that tissue stress histories play a major prosthesis interface . The multiple loading, stress history
role in regulating the biology of skeletal tissues, and that approach will then be applied and the differentiation of
these influences are stronger and appear earlier in skeletal the interface tissue will be predicted . Using different
development than has been previously thought . The equa- stress history criteria, we will thus predict the extent and
tions used to predict cartilage, bone, and mesenchymal tis- locations of bone ingrowth along the interfaces . Our
sue biology are similar to those that account for mechan- criteria will be adjusted and varied parametrically to
ical energy dissipation or the accumulation of fatigue represent the types of results which have been observed
damage in all materials . Our results may thus reflect funda- by others in experimental animal studies and clinical
mental characteristics of the transduction of mechanical retrievals . Subsequent bone remodeling around the
energy to chemical energy in living organisms . The con- prostheses will be calculated using the same algorithms
text in which this work is being conducted is porous coat- which had been previously verified for the normal tibia
ed/bony ingrowth prosthetic replacement of the proximal and femur.
femur and tibia . The end product of this research will be It is apparent that some design features may provide
a consistent framework of computer analyses which can good initial fixation and encourage bone ingrowth, yet
be applied to predict the biological events associated with lead to subsequent bone remodeling which is deleterious.
initial ingrowth and subsequent bone remodeling . We We will be able to address this issue with computer
anticipate that it will be possible to apply these approaches methods and thereby achieve a broad perspective of the
to the design and evaluation of any implant in the body. overall implications of various design features . We antici-
pate that from the analyses that we perform, certain
Methodology—In the course of our investigations, we design features will begin to emerge which will suggest
will generate three-dimensional finite element models of the evolution of cogent design principles for bony
the proximal femur and proximal tibia . The loading ingrowth total joint replacement . The proposed work
history over some period (e .g., an "average" day) will be represents a melding of basic and applied research . Our
specified by a series of discrete load cases applied for a theoretical approach to the regulation of skeletal tissue by
specific number of load cycles . The entire bone will he mechanical stresses will be explored and refined while it
represented initially by a solid, homogeneous structure is being applied to solve immediate design problems
with a constant bone density. Using a time-incremental which have a direct clinical impact.
bone remodeling technique, we will remodel the bone
computer models to create an internal distribution of Recent Publications Resulting from This Research
bone density and morphology which conforms to our
A Bone Surface Area Controlled Time-Dependent Theory for
bone remodeling theory. The resulting prediction of bone Remodeling (Abstract) . Beaupre GS et al ., Transactions of the
density distributions will be compared to those measured Orthopedic Research Society, 14 :311, 1989.
from cadaveric specimens. Our theory and computer Femoral Bone Architecture Computed from 3-D Models Relating
Bone Remodeling to Stress Histories (Abstract) . Orr TE,
approaches may then be modified so that our predictions Beaupre GS, Carter DR, in Proceedings of the XII International
correlate better with normal bone anatomy . Congress of Biomechanics, 167, 1989 .
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Orthopedic Implants
Mechanical Stresses in Skeletal Morphogenesis and Maintenance Computer Predictions of Bone Remodeling Around Porous-Coated
(Abstract) . Carter DR et al ., in Tissue Engineering 1989, Implants . Orr TE et al ., J Arthroplasty 5(3), 1990.
BED-14 :55-58, S .L-Y. Woo, Y . Seguchi (Eds .) . New York: Femoral Bone Architecture Computed from 3-D Models
ASME, 1989. Relating Bone Remodeling to Stress Histories (Abstract).
An Approach for Time-Dependent Bone Modeling and Remodeling— Orr TE, Beaupre GS, Carter DR, Orthop Res Soc 15 :77,
Application : A Preliminary Remodeling Simulation . Beaupre 1990.
GS, Orr TE, Carter DR, J Orthop Res 8 :662-670, 1990. Mechanical Stress Histories and Connective Tissue Differentiation
An Approach for Time-Dependent Bone Modeling and Remodeling— (Abstract) . Carter DR et al ., First World Congress of Bio-
Theoretical Development . Beaupre GS, Orr TE, Carter DR, mechanics, 11 :80, 1990.
J Orthop Res 8 :651-661, 1990. Numerical Methods for Emulating Stress-Induced Remodeling in
Computer-Aided Implant Design Using Bone Remodeling Algorithms the Femur (Abstract) . Beaupre GS, Orr TE, Carter DR,
(Abstract) . Orr TE, Beaupre GS, Carter DR, First World First World Congress of Biomechanics, 11 :200, 1990.
Congress of Biomechanics, 11 :192, 1990.
[356] High Viscosity Cooler Acrylic Bone Cement
F. Richard Convery, MD
University of California, San Diego, La Jolla, CA 92093 ; VA Medical Center, San Diego, CA 92161
Purpose—The fundamental purpose of this work has was to produce a high viscosity cement, we find that
been to identify methods to improve the fixation of changing the standard powder-to-liquid ratio from 2 .0 to
prostheses to bone in order to reduce the rate of failure 2.7 also affects other physical properties that should be
of cemented joint replacements, which are increasingly beneficial to long-term fixation of implants . Specifically:
required in the aging VA patient population . The effort is 1) the strength in compression is increased ; 2) the density
even more important at present than originally in that is increased ; and, 3) most importantly, the peak exotherm
cementless fixation of total joint prostheses, which was of the polymerizing composite is reduced by approxi-
very prevalent in the mid-portion of the 1980s, has mately 20 percent.
become less popular because of the frequency of intra- Currently, we are developing a delivery system that
operative complications and a 20-30% incidence of can be utilized in the clinical situation . Our canine and
postoperative thigh pain. goat total-knee model had a short (2 cm) cannulated
stem, and it was relatively easy to inject the high viscos-
Methodology—Previously, we have shown that external ity cement . For cemented hip replacement, retrograde
pressure applied to polymerizing bone cement : 1) increases injection of the femur requires a tube approximately 8
the shear strength of the cement itself; 2) increases the inches (20 cm) long . Since resistance to flow increases
shear strength of the bone cement interface ; and, markedly with length, we had to design and fabricate a
3) increases the penetration of cement into cancellous new delivery system . This has been accomplished by
bone . Conversely, we have shown that increasing the utilizing a hydraulic system that can be used to apply the
depth of penetration: 1) does not result in an improve- concept of high viscosity cement in the clinical setting.
ment in the shear strength of the bone-cement interface;
and, 2) most recently in work just completed we have Future Plans The delivery system works well in the
shown, in vivo, that the area of the interface fibrous laboratory, but before using it on humans we want to
membrane (an indicator of fixation failure) is directly refine the technique and establish the concept in vivo,
related to the depth of cement penetration into bone. which is the primary thrust of our current work.
With these observations in mind, we reasoned that
the advantages of external pressure on the bone cement Recent Publications Resulting from This Research
could be achieved without the disadvantage of excessive A Comparison of Intramedullary Plugs Used in Total Hip
penetration by increasing the viscosity of the cement Arthroplasty. Beim GM, Lavernia C, Convery FR, J
itself. This can be achieved by reducing the amount of Arthroplasty 4(2) :139441, 1989.
High Viscosity Acrylic Bone Cement . Hadjari M, Reindell ES,
monomer in the monomer/polymer mixture to increase Convery FR, Transactions of the 36th Annual Meeting of the
the powder-to-liquid ratio . Although our primary intent Orthopaedic Research Society, 29, 1990 .
282
The Effects of Cement Penetration on the Bone-Cement Interface Cardiopulmonary Function During Canine Total Knee Replacement
Membrane . Hadjari M et al ., Transactions of the 36th Annual Using Sustained Pressurization of Bone Cement . Weiner GM
Meeting of the Orthopaedic Research Society, 439, 1990. et al ., J Arthroplasty (accepted for publication).
[357] Effects of Treatment for Heterotopic Bone Formation

on Biological Fixation
Stephen D. Cook, PhD ; Kevin A . Thomas, PhD; Gregory C. Baffes, BSE ; Jeanette E . Dalton, BSE
VA Medical Center, New Orleans, LA 70146 ; Department of Orthopaedic Surgery, Tulane University School of Medicine,
New Orleans, LA 70112
Purpose—The purpose of this study is to evaluate the sacrifice ; and, 7) 18-week delay—indomethacin daily
effects of several short-term and chronic indomethacin beginning 18 weeks postoperative until sacrifice . Implan-
therapies on the amount of bone growth into a porous tation periods included 3, 6, 12, 18, and 24 weeks . This
surface and the bone-implant attachment strength. experimental design resulted in 26 treatments (combina-
Ectopic ossification following total hip arthroplasty tions of druglimplantation time) to be evaluated.
is a frequently reported complication . Treatments for the All animals (except controls) received 1 .0mm/kg/day
prevention of heterotopic bone have included diphospho- of indomethacin orally in two divided doses . Blood was
nate, radiation, and indomethacin therapies . Clinically, drawn at regular intervals during therapy to confirm
indomethacin has been shown to be effective in reducing blood/indomethacin levels.
ectopic bone formation, and effective in preventing After sacrifice, the implants were harvested and sub-
heterotopic bone formation induced by demineralized jected to mechanical push-out testing to determine inter-
bone matrix . Chronic indomethacin may significantly face attachment strength . The resulting data was analyzed
reduce the amount of bone growth into a porous implant, separately to examine the effects of implantation time and
as well as reduce the bone-implant attachment strength. drug treatment groups,
Since indomethacin is also used as an anti-inflammatory Intact and tested samples were evaluated using stan-
drug in several patient groups, the question arises as to dard undecalcified histologic techniques . The evaluations
what duration and at what period postoperatively does were based on qualitative gradings of mineralization and
indomethacin usage prohibit effective bone-porous osteoid formation, and computerized quantitative percent
implant attachment. bone ingrowth measurements.
Methodology—The animal model used was the skeletally Results—For each of the seven drug treatments there was
mature mongrel canine approximately 18 to 22 kg in a significant effect of time of implantation upon shear
weight . Cylindrical Ti-6A1-4V alloy implants, 5 .1mm in strength (all p<0.0025) as follows : Control group—
diameter by either 18mm or 20mm length, were coated significant increase in strength from 6 to 12 to 18 weeks;
with a two-layer spherical bead Ti-6Al-4V alloy porous Heterotopic indomethacin group—average strengths sig-
coating . The implants were placed in the femoral bone nificantly lower at 6 weeks as compared to 12 and 18
through both cortices using strict aseptic techniques; weeks ; Chronic indomethacin group—strength data
each animal received 5 to 6 implants bilaterally. increased significantly from 3 to 6 to 24 weeks . Strengths
Animals were randomly assigned to the following for animals receiving indomethacin after a 3-, 6-, or
groups: 1) Controls—no drugs ; 2) Chronic—indomethacin 9-week delay were significantly greater at the 24-week
daily for 2 weeks preoperative until sacrifice ; 3) Hetero- interval.
topic—indomethacin immediately postoperative con- Evaluation of the strength data after 6 weeks demon-
tinued daily for 6 weeks ; 4) 3-week delay—indomethacin strated a significant drug group effect (p < 0 .05), with the
daily beginning 3 weeks postoperative until sacrifice; strength values for the Chronic indomethacin group
5) 6-week delay—indomethacin daily beginning 6 weeks significantly greater than the Control and Heterotopic
postoperative until sacrifice ; 6) 9-week delay- groups . Similar results were observed at the 24-week
indomethacin daily beginning 9 weeks postoperative until time period, with the strengths for the Chronic in
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Orthopedic Implants
domethacin group significantly greater than the 3-,6-, 9-, remains unclear, strengths appear to be unaffected by a
and 18-week delay groups . After 12 and 18 weeks implan- delay of 6 weeks or longer.
tation, there were no significant differences in strength
among the drug groups (p=0.25).
Implications—These results indicate that indomethacin Effects of Treatments for Heterotopic Bone Formation on Biologic
Ingrowth Fixation . Thomas KA, Cook SD, Brinker MR, Digest
given strictly postoperatively has no consistent detrimen- of Papers Eighth Southern Biomedical Engineering Conference,
tal effect upon fixation strength . It was unexpected that Richmond, VA, 1989. (Abstract published in Biomater Artif
animals receiving chronic indomethacin would exhibit Cells Artif Organs 17:515, 1989 .)
Effects of Indomethacin on Biologic Ingrowth Fixation . Poster
greater strength values ; perhaps a longer preoperative exhibit, 16th Annual Meeting of the Society for Biomaterials,
therapy would have altered these findings . While the Charleston, SC, 1990 . (Abstract published in Transactions,
effect of indomethacin given strictly postoperatively XIII :231, 1990.)
[358] Effect of Surgical it on the Biological and Mechanical Response

to Porous-Surfaced Implants
Stephen D. Cook, PhD ; Kevin A . Thomas, PhD ; Jeanette E. Dalton, BSE ; Gregory C . Baffes, BSE
VA Medical Center, New Orleans, LA 70146 ; Department of Orthopaedic Surgery, Tulane University School of Medicine,
New Orleans, LA 70112
Purpose The purpose of this study is to investigate the mately 100.0mm long. Three different disc arrange-
effects of a uniform gap space between a porous implant ments were used for each time period, allowing two
and surrounding bone on the degree and maturity of bone discs of each diameter to reside in the cancellous (meta-
growth into the porous surface, and to determine the physeal) region and the cortical (diaphyseal) region of
effect of the gap upon interface attachment strength . The the femur.
implant design assures the presence of uniform gap The animal model was the skeletally mature mongrel
spaces of varying sizes between the implant surface and canine ranging in weight from approximately 18 to 22kg.
the surrounding bone, and also allows for evaluation in Identical implants were inserted bilaterally into the
regions of cortical and cancellous bone. femoral intramedullary canal using standard aseptic tech-
Ideally, a porous-surfaced implant relying on bone niques . Five animals at each implantation period (4, 8,
ingrowth fixation should make initial apposition with the 12, 24, and 52 weeks) were randomly assigned one of
surrounding bone . Unfortunately, this is not always three implant arrangements.
achieved surgically at all locations and a space between Harvested femurs were sectioned by cutting through
the implant and bone is present . This space may be the the acrylic spacers to produce individual test specimens.
result of deficiencies in instrumentation design, implant These specimens were mechanically tested with a spe-
design, or surgical technique . The gap may severely alter cially designed push-out fixture to determine interface
the type, amount, and rate at which tissue infiltrates the shear attachment strength.
porous-implant surface . Thus, the development of sig-
nificant fixation strength may be delayed and the ultimate Future Plans/Implications—Both tested and intact
attachment strength adversely affected. specimens will be processed using undecalcified tech-
niques to produce histologic and microradiographic
Methodology—Femoral intramedullary implants were sections for evaluation . The amount of maturing bone
constructed by threading Ti-6A1-4V alloy porous coated growth in apposition to and within the porous surface, as
discs of 6.0, 8.0, 9.0, and 10.0mm diameters onto a central well as the amount of gap filling will be quantified on all
2mm threaded rod . Each implant consisted of four histologic specimens . The data will be analyzed to deter-
4.0mm thick discs of each diameter, separated by solid mine differences among the implants in cortical and
acrylic spacers 10.0mm in diameter and approximately cancellous bone regions as well as any differences in
2.0mm thick . The assembled implants were approxi- medial, lateral, posterior, or anterior locations .
284
This study will determine' the limits of the ability of as well as evaluating how the response may differ between
new bone growth to fill a gap space at various time periods . cortical and cancellous bone . This information will help
The effects of bone ingrowth and gap filling upon the resul- answer many questions critical to the design and use of
taut interface attachment strength will also be determined, noncemented porous-coated devices in the clinical setting.
[359] Optimization of Orderly Oriented Wire Mesh

for Prosthetic Arthroplasty
John M . Cackler, MD
VA Medical Center, Philadelphia, PA 19104
Sponsor: VA Rehabilitation Research and Development Service (Project #A356-2RA)
Purpose—Orderly oriented wire mesh (OOWM) is a The optimized K t developed from this model will then
pure titanium porous coating which represents a unique be validated through the mechanical testing of a range of
approach to the biologic fixation of hip or knee implants . sinterneck radii to validate the results of the FEA model.
Prior work supported the utility of the material for bio- This will then allow the design of an OOWM that should
logic fixation of implants in a canine model . This study minimize reduction in fatigue strength over traditional
seeks to optimize the performance of material through the sintered surfaces.
use of both in vivo and in vitro models . The second hypothesis will be investigated using in
vivo analysis of pull-out resistance of implants with
Methodology—Three hypotheses will be studied : 1) that pore structures different in size from that already inves-
optimization of the geometry of the mesh-substrate inter- tigated, in an attempt to optimize the strength of biologic
face will minimize the reduction in fatigue strength of the fixation of OOWM-coated implants. Two additional
sintered implant ; 2) that biologic fixation of the OOWM OOWMs with substantially different pore sizes will
can be optimized by appropriate manipulation of the be investigated.
dimensions of the mesh wires and weave ; and, 3) that The third hypothesis will examine the fatigue
OOWM-coated prostheses will offer enhanced fixation of strength of the OOWM-PMMA cement interface, in an
the implant to PMMA bone cement, without compromis- effort to demonstrate enhancement of cement implant
ing cement fatigue and static properties . shear and fatigue performance compared with uncoated
The first hypothesis will be investigated through implants . This will require in vitro mechanical testing
development of a two-dimensional finite element model and fractographic analysis in order to validate the use of
of the stress concentration (Kt) at the sinterneck interface . OOWM for cemented implants.
[360] Evaluation and Examination of Retrieved Porous-Coated

Orthopaedic Prostheses
John P. Collier
VA Medical Center, White River Junction, VT 05001 ; Thayer School of Engineering, Dartmouth College,
Hanover, NH 03755
Sponsor : VA Rehabilitation Research and Development Service (Project #A473-DA)
Purpose—The overall objective of this study is to assess location of porous coating on the prosthesis, coating
the long-term feasibility of porous coating as a mecha- pore size, pore geometry, pore density, and surface
nism for fixing orthopaedic prostheses to bone. roughness on the resulting interface between the prosthe-
This examination of clinically retrieved, porous- sis and bone . The study will address the issues of stress
coated hip and knee prostheses will assess the importance shielding, ion release and wear debris formation, and,
of such variables as material composition (cobalt and where possible, clarify causal relationships with prosthe-
titanium-based alloy systems), design (implant geometry), sis parameters .
285
Orthopedic Implants
Methodology—Retrieved prostheses are fixed in formalin Mechanisms of failure of patellar and tibial components
for 48 hours, examined macroscopically for both soft and included : separation of polyethylene from the metal
hard tissue apposition to the prosthesis and mapped for backing, wear-through of the polyethylene, cracking,
the location of this tissue . The prosthesis is coarsely pitting, and delamination of the articulating surface, as
sectioned and the large sections are dried in a series of well as deformation of the polymer due to creep . Exami-
alcohol and acetone solutions . Fully dried prosthetic nation of the ingrowth surfaces of tibial and patellar
components are embedded in ethyl-methacrylate and cut prostheses which had been retrieved for reasons of poly-
into sections approximately 1 mm thick . These sections ethylene failure often demonstrated polyethylene wear
are hand-ground to between 20 and 4014 in thickness and debris at the margins of the porous coating which appears
hand polished . Specimens are stained with either to be associated with localized osteoclastic activity and
hematoxylin and eosin (H and E) or acid phosphatase, bone resorption.
cover-glassed and photographed on a Zeiss photomicro- Several surprising phenomena not previously reported
scope III . The interface is mapped and evaluated for bone were documented through the prosthesis examination
and fibrous tissue ingrowth, osteoclastic and bone process this year. These included : 1) the deformation and
resorptive activity, and the presence of polyethylene or high wear rate of the thin polyethylene inserts used in
metal wear debris. metal-backed acetabular components ; 2) the considerable
wear of titanium heads used in femoral hip prostheses;
Results—In the past 12 months, we have examined 378 3) corrosion at the interface between cobalt alloy heads
retrieved, porous-coated orthopaedic prostheses . This and titanium alloy femoral hip stems ; 4) separation of
compares favorably with the 249 prostheses examined in bone-ingrown titanium wire mesh pads from the substrate
the first year of this project . One hundred and ninety-five of femoral hip prostheses ; and, 5) the loss of material
hip prostheses were received from 85 surgeons ; 183 knee from some plasma-sprayed and sintered bead porous
prostheses were received from 48 surgeons . Eighteen of coatings that migrated to the articular surfaces resulting
the 378 prostheses were retrieved post mortem from in early failure of the polyethylene and significant wear
cadaver specimens. of the metal components.
Bone ingrowth of large and small pore sizes of both
titanium and cobalt alloy was demonstrated . The amount
extent of bone ingrowth was found to be a function of
implantation duration and implant design and fixation The Case for Pressfit Femoral Stem Fixation . McCutchen JW,
Collier JP, presented at the 18th Open Scientific Meeting of The
mechanisms. Hip Society, New Orleans, 1990.
Bone ingrowth of femoral hip prostheses, femoral Early Failure of Polyethylene Components in Uncemented Total
knee prostheses, and patellar prostheses was frequently Knees . Surprenant VA et al ., presented at the 57th Annual
Meeting of the American Academy of Orthopaedic Surgeons,
seen . Bone ingrowth of acetabular prostheses was much New Orleans, 1990.
less frequently seen ; bone ingrowth of tibial prostheses Examination of Porous-Coated Patellar Components and Analysis
was seen least frequently of those device types evaluated. of the Reasons for Their Retrieval . Collier JP et al ., presented
at the 57th Annual Meeting of the American Academy of
Tibial prostheses with porous-coated central pegs demon- Orthopaedic Surgeons, New Orleans, 1990.
strated bone ingrowth of the central peg more frequently The Success of Pegs, Stems and Screws as Adjuvant Means of
than ingrowth of the porous-coated plateau . The most Fixation of Tibial Prostheses as Measured by Radiographic and
frequent bone ingrowth of the underside of the tibial Histological Examination . Collier JP et al ., presented at the 57th
Annual Meeting of the American Academy of Orthopaedic
plateau was seen with prostheses fixed with four metal Surgeons, New Orleans, 1990.
screws . Generally, there was evidence of metal fretting Biological Ingrowth of Porous-Coated Knee Prostheses . Collier JP
between the screws and the screw holes and the local et al ., in Controversies of Total Knee Arthroplasty : Issues of the
Nineties . New York : Raven Press (in press).
tissue had often turned black . Metal ion concentrations in The Biomechanical Problems of Polyethylene as a Bearing Surface.
this tissue was measured as greater than 1% by weight Collier JP et al ., Clin Orthop Rel Res (in press).
in several cases. The Case for Pressfit Femoral Stem Fixation . McCutchen JW,
Collier JP, Clin Orthop Rel Res (in press).
Worn polyethylene articular surfaces and the devel- Corrosion at the Interface of Cobalt-Alloy Heads on
opment of significant amounts of polyethylene wear Titanium-Alloy Stems . Collier JP et al . ; J Bone Joint Surg
debris was seen in a high percentage of knee prostheses . (in press) .
286
[361] Surface Failure in UHMWPE Joint Components

Timothy M . Wright
Hospital for Special Surgery, Department of Biomechanics, New York, NY 10021
Sponsor : National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health
Purpose The purpose of this research is to establish patterns were measured and predicted with finite element
failure criteria for the articulating surfaces of ultrahigh modeling . Maximum shear stress was located at a depth
molecular weight polyethylene (UHMWPE) components of 1 or 2 mm in tibial components . This compares favor-
used in total joint replacement systems, and to apply ably with the depth of pits and delaminations seen in these
these criteria to optimize implant design . Observations of materials . Nonconforming surfaces in some modern knee
retrieved components have revealed distinct patterns of joint designs (e .g., cruciate ligament sparing devices)
damage, apparently caused by fatigue fracture mecha- have much larger stress on the components.
nisms . The design decisions for UHMWPE components
are based on the assumption that particular stresses and Future Plans/Implications—We plan to determine the
stress distributions (i .e ., the maximum shear stress and relationship between the crack growth rate and the
the range of maximum principal stress) are responsible applied cyclic stress intensity . Previous work showed that
for causing damage . To verify the direct relationship this relationship is insensitive to standard processing
between specific stress states and the production of surface techniques in the opening mode . This work will examine:
damage, the conditions under which growing fatigue cracks 1) effects of mixed-mode loading conditions, under which
in UHMWPE will change direction must be established. the propagating crack could be expected to change direc-
Our goal is to determine the cyclic loading conditions tion, with the fatigue crack propagation rate and crack
which will cause small defects on and below the surface trajectory being a function of both the opening mode
to propagate and create the observed damage . The approach (Mode I) and sliding mode (Mode II) stress intensity
is based upon principles of fracture mechanics. factors ; 2) effects of a new type of UHMWPE, made by
a processing technique which alters the mechanical and
Methodology—Test variables will be the angle of inclina- physical properties, and can be expected to alter the
tion of the crack relative to the direction of the applied fatigue crack propagation behavior beyond the inconse-
loading and the state of preconditioning of the material quential differences found previously between the extruded
under uniaxial cyclic loading prior to testing . Tests will and molded versions of conventional UHMWPE ; and,
be conducted on specimens made from both conventional 3) effects of preconditioning or working the material,
UHMWPE and enhanced forms of UHMWPE . Empirical which will occur under the high intensity cyclic loads
relationships will be used as input to a numerical model to applied to the articulating surface of an implant prior to
demonstrate that the method correctly predicts fatigue crack crack initiation, and which can be expected to affect the
propagation in UHMWPE . This will be accomplished by material properties and the fatigue crack propagation
modeling the test specimen geometry and loading condi- relationship for UHMWPE.
tions from the fatigue tests and comparing the computed We will then use the empirical relationships in a two-
crack propagation rates and direction with those measured dimensional, plane strain, numerical method based on
experimentally. If fatigue crack propagation in UHMWPE linear elastic fracture mechanics and demonstrate that the
cannot be described on the basis of linear elastic fracture numerical method correctly predicts fatigue crack propa-
mechanics, the analytical method will be modified to gation in UHMWPE by modeling the test specimen
include nonlinear material behavior around the crack tip. geometry and loading conditions from aim one and
comparing the computed crack propagation rates and
Progress/Preliminary Results—Fatigue crack propagation directions with those measured experimentally.
resistance of enhanced polyethylene was determined to be
isotropic and more resistant to crack propagation than con-
ventional polyethylene . Preconditioning was found to affect
crack failure properties . Extensive evaluations were made The Effect of Waveform and Compressive Loading on the Fatigue
Crack Propagation Behavior of UHMWPE . Rimnac CM, Wright
of various stresses produced in joint surface contact between TM, Klein RW, in Transactions of the 35th Orthopedic Research
the metal and polyethylene components . Complex stress Society Meeting, 14 :487, 1989.
287
Orthopedic Implants
[362] Cell Response to Modified Ti Surfaces (Rats)
John C. Keller
University of Iowa College of Dentistry, Iowa City, IA 52242
Sponsor : National Institute of Dental Research, National Institutes of Health
Purpose—Dental implants fabricated from titanium (Ti) and proliferation on these surfaces) will be ascertained.
and Ti-6AI-4V alloy are widely used in clinical practice, We hypothesize that chemical and biochemical modifica-
yet there is no consensus or established criterion regard- tions of the implant surface will result in enhanced
ing the design or fabrication of implant surfaces . As a biological acceptance and long-term tissue integration.
result, there is little information currently available con-
cerning specific biological responses, such as deposition Implications—This type of research has far-reaching
of extracellular matrix molecules and attachment of cells, clinical implications in that it will define a model implant
which occur during the initial stages of wound healing at surface which can foster improved tissue reactions,
the intimate implant and hard and soft tissue interfaces. thereby potentially decreasing the long healing periods
The overall objective of this research is to investigate now necessary with most commercial implant systems.
some of the cell responses to standard, commercially
available implant surfaces, as well as to modified Recent Publications Resulting from This Research
Ti-based implant surfaces . Preliminary data from our lab Characterization of Acid Passivated cpTi Surfaces . Keller JC et al .,
suggest that available implant systems vary widely in J Dent Res 68 :872, 1989.
In Vitro Cell Attachment to Characterized cpTitanium Surfaces.
surface topography and that molecular interactions and Keller JC et al ., J Adhesion 28 :115433, 1989.
attachment of cells at these surfaces are affected by the Surface Characteristics of Prepared cpTi Implants . Keller JC et al .,
nature of the substrate. Transactions of the First International Congress on Dental
The experiments in this project are specifically Materials, 271-272, 1989.
Bacterial Adhesion to Titanium Surfaces : Development of an In
designed to study a number of variables by surface Vitro Model . (Abstract) Patel M, Drake DR, Keller JC, J Dent
characterization techniques, including scanning electron Res 69 :369, 1990.
microscopy (SEMIEDAX), electron spectroscopy for Development of a Model for Cell Attachment . (Abstract) Clavin TJ
et al ., J Dent Res 69 :369, 1990.
chemical analysis (ESCA), auger electron spectroscopy In Vitro PDL Fibroblast Attachment to Plasma Cleaned cpTi
(AES), and surface energy (contact angle) measurements. Surfaces. (Abstract) Michaels CM et al ., J Dent Res 69 :369,
The effects of variables such as type of metal, surface 1990.
topography, oxide structure and composition, and surface Protein Adsorption is Decreased on Glow Discharged Treated cpTi.
(Abstract) Stanford CM et al ., J Dent Res 69 :369, 1990.
charge and energy on fundamental biological events (such Role of Integrin Receptors in Osteoblast Attachment to cpTi.
as matrix adhesion, cellular attachment, and spreading Stanford CM, Keller JC, Solursh M, J Dent Res 69 :109, 1990.
[363] Titanium and Ti-6A1-4V Alloy Implant Fabrication (Rabbits)
Raymond A . Kopczyk
University of Kentucky College of Dentistry, Oral Health Practice, Lexington, KY 40536
Sponsor : National Institute of Dental Research, National Institutes of Health
Purpose The long-term objective of this investigation is provide the mechanism for constructing superstructures
to use a new process, electro-discharge compaction, for for any titanium or titanium alloy implants to mini-
custom designing porous titanium and titanium alloy mize corrosion.
implants and superstructures . The ultimate goal is to
develop a method whereby tooth roots can be duplicated Methodology—Preforms will be developed that will
and the resulting implants can be placed in extraction satisfy criteria for titanium and titanium alloy dental
sockets within 24 hours of extraction . This would implants by varying energy input . This project will
minimize surgical complications and provide an inexpen- evaluate the surface characteristics of the preforms to
sive means for replacing teeth . The method should also determine the character of the surface, the oxide layer,
288
the chemical composition of the contaminants, pore size, titanium alloys that can be used to evaluate the biocom-
and grain structure as the energy input is varied . When patibility of the preforms fabricated with the new tech-
the preform technique is perfected and consistent results nique. Rabbits will be used to determine soft tissue and
can be attained, the electro-discharge compaction bone tissue compatibilities . Osseointegration capabilities
method will be used to prepare preforms of titanium and will be determined.
[364] Ion Sputter Deposition of Ca-P Thin Films
Linda C. Lucas, PhD ; William R . Lacefield, PhD

Department of Biomaterials, University of Alabama at Birmingham, Birmingham, AL 35294
Sponsor : National Science Foundation
PurposeThe overall goal of this research project has tion of each coated specimen . For the solubility studies,
been to coat metallic materials with biocompatible Ca-P coated samples were exposed to a 0.9% NaCl solution for
ceramic materials using the ion-beam sputter deposition varying time periods after which the coatings were evalu-
process . Most orthopedic and dental implants are con- ated using SEM and EDS analyses.
structed of metallic materials such as titanium or cobalt- In general, the as-sputtered coatings produced the
based alloys . A number of ceramic materials containing highest bond strengths while the heat treatments sig-
calcium and phosphorus have found increasing use for nificantly reduced the adhesion of the coatings . One
biomedical applications due to their biocompatibility and exception was observed . The heat-treated coatings
ability to form a chemical bond with bone . However, produced with Glass-II exhibited bond strengths as
these particular ceramics are brittle and are not suitable high as those observed for the as-sputtered coatings.
for use in load-bearing implant applications, so their For the solubility evaluations, all as-sputtered coatings
optimum use for most medical and dental applications dissolved within 1 to 3 hours after immersion in the
may be as coatings on metals. saline solution . The heat-treated coatings produced
with the HA-FA target remained after 6 weeks and thus
Methodology—The ion-beam sputter coating process had the lowest solubility . The heat-treated coatings
used in this study employs high velocity gas ions to dis- produced with Glass-I and Glass-II targets dissolved
lodge atomic fragments of ceramic target materials, within 1 to 4 days.
which in turn will coat metallic implants placed in the
path of the sputtered material . For this study, three target Future Plans—Additional efforts on this study will con-
materials have been used : a hydroxyapatite-fluorapatite centrate on the optimization of coating chemistry and
(HA-FA) target, and two high phosphorus glass targets. structure . Coating chemistry will be controlled by the use
The HA-FA target has a Ca/P ratio of 1 .67, whereas of different ceramic targets such as : 1) glasses containing
Glass-I, a calcium metaphosphate glass with the chemi- higher Ca content materials ; and, 2) glass and ceramic
cal formula Ca(PO3)2 , and Glass-II, a commercially targets containing F. By controlling the composition of
obtained calcium phosphate glass (Glass-II) with a 2 % these glass targets, a coating chemistry more similar to
silica addition, have a Ca/P ratio of 0.5. Titanium discs hydroxylapatite may be obtained . The structure of the
(1 cm diameter, 2 mm thick) were coated by sputtering coatings will be controlled by optimizing post deposition
each of the three targets . As the sputtered coatings are heat treatments used for the production of crystalline
amorphous, heat treatments were employed to obtain phases in the as-sputtered coatings . The use of vacuum
crystalline phases in the coatings. and controlled atmosphere heat treatments will be inves-
tigated to determine if both high crystallinity and high
Results—The bond strengths and solubility of as-sputtered bond strength of the Ca-P coatings can be achieved . The
and heat-treated specimens have been evaluated . Bond most important goal in next year's work is to maximize
strength of the coatings to the substrates were determined crystallinity as a means of reducing coating solubility
using the Sebastian V z-axis tensile bond tester . Reflected while maintaining a sufficiently high bond strength of the
light microscopy was used to find the exact failure loca- coating to the metallic substrate .
289
Orthopedic implants
Recent Publications Resulting from This Research ESCA Analysis of Passivated Titanium and Ca-P Surfaces . Harris
JL et al ., Transactions of the Sixteenth Annual Meeting of the
Characterization of an Ion-Beam Sputter Deposited Calcium Society for Biomaterials, 44, 1990.
Phosphate Coating . Rigney ED et al ., International Association The Optimization of Ca-P Ion-Sputtered Thin Films . Gantenberg B
for Dental Research Program and Abstracts, 835, 1990. et al ., International Association for Dental Research Program
The Effect of Heat Treatments of Ion-Beam Sputter Deposited Cal- and Abstracts, 197, 1990.
cium Phosphate Coatings . Rigney ED et al ., Transactions of the
Sixteenth Annual Meeting of the Society for Biomaterials, 13, 1990 .
[365] Ion I mplantation to Reduce Wear on Polyethylene Prosthetic Devices
Piran Sioshansi
Spire Corporation, Bedford, MA 01730
Purpose—Spire Corporation is continuing its research in relationship between surface finish and wear results . The
the surface modification of Ultra-High-Molecular-Weight- effect of the vacuum environment during and after pro-
Polyethylene (UHMWPE) through the use of ion beam cessing on the performance of the UHMWPE was also
processing . The National Science Foundation (NSF) studied. Raman spectroscopy has been used to analyze the
Phase I program was successful in identifying the ion modified surface microstructure . Rutherford backscatter-
beam processing parameters which can provide UHMWPE ing spectroscopy (RBS) is used as an additional analysis
with increased microhardness and reduced coefficient of tool . RBS has shown a significant increase in carbon at
friction. The goal of the NSF Phase II effort, which com- the surface of the treated UHMWPE which indicates a
menced August 1, 1989, has been to investigate the modi- densification of the near surface region . This phenomenon
fied surface properties of ion beam-processed UHMWPE. contributes to the improved properties of the material.
The treated UHMWPE will be studied in wear simula-
tion against Ti-6Al-4V and Co-Cr alloys. Future Plans—Based on the results of the Phase I and II
studies, several large orthopedic firms have expressed con-
siderable interest in applying the ion implantation process
Methodology—Based on the preliminary results from
to the articulating surfaces of UHMWPE components of
the Phase I study, the Phase II effort concentrated on
prosthetic devices . To date, our research has mainly been
studying the wear performance of ion beam-processed
from a materials approach, while the orthopedic manufac-
UHMWPE in simulated wear environments . The Phase
turers must approach new processes with the goal of ulti-
I program showed that ion implantation of various ion
mate FDA approval and widespread use . For these reasons,
species into UHMWPE increased microhardness and they must address concerns such as biological response
reduced coefficient of friction, The ion beam parameters to the treated UHMWPE and potential harmful effects, if
for this processing were established . In the Phase II pro- any. Additionally, since the marketing of orthopedic devices
gram, ion-implanted UHMWPE test disks were tested is a major consideration, the cosmetic implications of a
against Ti-6Al-4V and Co-Cr alloy pins . The pin-on-disk "different" material must be assessed . These concerns are
apparatus was specially designed to enable testing in both being studied in parallel with the NSF program in hopes
Ringer's solution and bovine serum . Physiological loads of reducing the time to market.
were used in the testing . Test results showed a 60% Following the Phase II program, it is our goal to
reduction in polyethylene wear tracks and a marked team up with an orthopedic manufacturer and test the
reduction in the UHMWPE wear debris generation. ion beam-processed UHMWPE in knee and hip joint
Coefficient of friction measurements were also made simulators.
during testing, and results showed a 15% improvement in
both the Ringer's solution and bovine serum.
Patents
Results—Ongoing investigation has included studies of Ion Implantation of Plastics . Patent Number : 4,743,493 ; Date of
Patent : May 10, 1988.
the relationship of the surface finish of the UHMWPE to Ion Implantation of Polyethylene Orthopedic Implants . Patent
the wear results . Initial findings indicated a strong inter- applied for: July 31, 1990.
290
B. H P
[366] Epiphyseal Hip Replacement : A Pilot Study
Dennis R . Carter, PhD ; Tracy E . Orr, PhD

Sponsor : VA Rehabilitation Research and Development Service (Pilot Project W3987-PA)
Purpose—Conventional total hip joint replacement is a a result of these bone remodeling simulations, initial
highly successful surgical procedure for treatment of design modifications could be made prior to implanta-
severe arthritis of the hip . However, the incidence of tions in animals or humans.
mechanical loosening and stem fracture has become an In conjunction with the computer modeling studies,
increasingly significant problem, especially in younger a series of laboratory prototypes was also created . The
patients . This has renewed interest in conservative alter- prototypes were used to : 1) develop the necessary surgi-
natives . One such alternative is our epiphyseal replace- cal instrumentation ; and, 2) test different designs used
ment prosthesis, a new research-based design which for initial implant stability. The instrumentation consists
incorporates the interface contours suggested by the of two reamers that are used sequentially to prepare the
geometry of the epiphyseal plate or scar. femoral head for prosthetic seating . A set of nine spikes
(1 .0 mm in diameter and 5 mm in length) is used to pro-
Methodology—Using engineering design and finite ele- vide initial stability and to encourage bony ingrowth.
ment analysis techniques, we have attempted to improve Due to unforeseen manufacturing difficulties, titanium
on the generic type of hip surface replacement by critical prototype prostheses for the in vivo animal study have not
design changes which appear to be of major benefit on a yet been completed . Additional computer models and
theoretical basis. laboratory prototypes have been completed . Although it
is not possible to obtain the precise time course of bone
Progress—During this 1-year pilot project, computer remodeling without the use of in vivo implantation, the
modeling and laboratory testing of a new epiphyseal hip computer simulations lend additional support for the
surface replacement was completed . The results of the efficacy of the epiphyseal replacement concept.
computer modeling are reported in the article listed
below. The computer analyses used a state-of-the-art Recent Publications Resulting from This Research
bone remodeling algorithm to simulate the bony adapta- Computer Predictions of Bone Remodeling Around Porous-Coated
tion caused by the presence of the prosthetic implant . As Implants . Orr TE et al ., J Arthroplasty 5(3), 1990.
[367] Quantitative Analysis of Total Hip Arthroplasty

on Stress and Strain
Gary J . Miller, PhD ; Donna Wheeler, MS ; R . William Petty, MS, MD

VA Medical Center, Gainesville, FL 32602 ; Department of Orthopaedics, College of Medicine,
University of Florida, Gainesville, FL 32610
Purpose—Total hip arthroplasty design continues to Preliminary Results—Assessment of the overall strain
evolve as the need for long-term reconstruction perfor- distributions, using optical methods for strain assess-
mance enhancement persists . Assessment of new design ments to replace strain gauges, has been carried out . This
features requires quantitative comparative data on the noncontact full-field assessment tool would he of great
effect of both design and materials selection on the value in continued research in total joint replacement.
stresses and strains seen by the bone so that a biologically Holographic interferometry (HI) allowed for the success-
effective reconstruction can be affected . ful qualitative assessment . Finite element comparisons
291
Orthopedic Implants
correlated well with these preliminary results . In an Future Plans/Implications—The next step of the experi-
effort to gain more quantitative information, speckle ments will be to auto-acquire speckle data with a video
shearing interferometry (SSI), another optical method, camera system . This system allows electronic filtering of
has been utilized . It allows optical differentiation of the frequency modulated speckle patterns, thus improv-
displacement data so that errors of mathematical ing the fringe location and subsequent strain assessments.
differentiation may be reduced . To date, a simplified Development of these computerized assessment tools
cylindrical Plexiglas" model of the femur has been continues as cadaveric proximal femurs with implants are
tested . Theoretical predictions and finite element assessed . This will allow assessment of press-fit porous-
modeling and strain gauge data have correlated well. coated devices with various geometric configurations,
These results also show excellent reproducibility . Effec- including "off the shelf' designs and custom prostheses,
tive utilization of SSI, however, requires the develop- thus leading to quantitative information on the effects of
ment of computerized automated fringe interpretation these new implant designs on femoral bone strain in this
methodologies to allow quantified analysis of the altera- immediate postoperative model.
tion of surface strain following prosthesis implantation.
In addition, early work using SSI was applied to flat Recent Publications Resulting from This Research
two-dimensional (2-D) objects . To validate our tech- Applied Optics in Biomechanics . Wheeler D, Chitsaz B, in
nique for three-dimensional (3-D) objects, a series of Proceedings of the Photo-Mechanics Conference, Blacksburg,
experiments has been carried out over the last year. VA, 15-17, 1990.
Double exposure plates yielded data for analysis using Biomechanical Assessment of "Screw-In" Metal-Backed Acetabular
Prostheses . Miller GJ, Wheeler D, Petty RW, in Proceedings of
a prototype computer system . Calibration of the proto- 1st World Congress of Biomechanics, San Diego, 1990.
type system of fringe analysis indicates ± 4% accu- Evaluation of Allograft Fixation . Vander Griend R, Sollaci C,
racy. Defocusing led to significant errors . These Miller GJ, in Proceedings of 5th International Symposium on
Limb Salvage Surgery (in press).
problems were obviated by using f/stops that were Total Hip Replacement: Biomechanics and Design . Miller GJ, in
smaller (increasing depth of field), and increasing Total Joint Replacement, W. Petty (Ed .) . Philadelphia : W.B.
exposure time . Saunders Company (in press).
[368] Rehabilitation Implications of In Vivo Hip

Pressure Measurements : Part 1
John A. McA. Harris, MD ; Robert W. Mann, RD

VA Medical Center, Jamaica Plain, MA 02130 ; Newman Laboratory for Biomechanics and Human Rehabilitation,
Mechanical Engineering Department, Massachusetts Institute of Technology, Cambridge, MA 02139
Purpose—How cartilage distributes the time- and characteristics of cartilage, bone, and synovial fluid syn-
position-varying load across a synovial joint is of interest ergize locally and globally to achieve high load capacity,
clinically as it relates to the longevity of endoprosthesis low-friction, long-wearing skeletal bearings.
implantation following femoral head or neck trauma or Prior to our research, only sparse in vitro data from
necrosis . Migration of the implant through the acetabular rather gross experiments were available on the magnitude
cartilage is common : a 50% incidence of protrusion four and distribution of contact stress in synovial joints . In
years postoperatively has been reported . Pathologically, general, these studies described the natural global joint
cartilage pressure distribution is central to the possible as distributing the load vector into a more-or-less
role of mechanical factors in the etiology of osteoarthritis, uniform or axisymmetrical distribution with maximum
acting either directly (e .g ., collagen fiber rupture), or pressures not much higher than that calculated by divid-
through mechanical/biological coupling (e .g., the influ- ing estimates of the load magnitude by estimates of the
ence of the mechanical microenvironment on chondrocyte area of interarticular cartilage contact . This "average"
metabolism and expression) . Scientifically, pressure dis- pressure is about 2 to 3 megapascals (MPa).
tribution information is a crucial element in the basic Cartilage per se is a relatively soft, poroelastic
understanding of how the mechanical and biological matrix which is saturated with fluid . When small plugs
292
of cartilage are loaded to permit fluid drainage, the intrin- temperatures caused the expression of "heat-shock" pro-
sic or network modulus is measured at about one MPa. teins . The Berlin group has recently reported similar
Mathematical models of simplified joints studying fluid temperature rise in vivo from their force-instrumented
circulation have in fact postulated free-draining or porous total hip replacement prosthesis . To better monitor tem-
sliders, influenced apparently by the plug experiments. perature on and in the endoprosthesis, a dummy pressure
transducer diaphragm was added and instrumented with
Methodology—After considering different approaches to a thermistor. This detector will also be used in a feedback
experimentally quantify local pressures and their distri- control system to reduce the power inductively trans-
bution in the human hip joint, we chose to integrate mul- mitted from the external coil to the antenna on the stem
tiple pressure transducers into the load-bearing surface of of the prosthesis.
a pseudofemoral head, in part because hemiarthroplasty The electronic package which converts the pres-
is a common surgical response to femoral head or neck sures, expressed as the strain-gauge signals, from the
damage. Thus, in vivo instrumented endoprosthesis data individual flexing beams to a pulse-amplitude-modulated
are relevant to a significant patient population and the signal for frequency modulation telemetry outside the
surgeons who service them . These data are also pertinent human body, was extensively redesigned . Restudy
to scientific understanding of normal and pathological resulted in part from changes and improvements in elec-
synovial joint tribology and the etiology of osteoarthritis. tronic components since the original unit was designed
(large-scale integrated circuit "chips") and in part to
Results—The first prosthesis was implanted in 1984, and increase the number of channels from 16 to 32 to
produced extensive data for over 5 years (see Part 2). accommodate the temperature measurements, the power
A second prosthesis was implanted in the fall of feedback control, and the future force vector and
1990. Significant design improvements have been incor- moment measurement.
porated based on experience with the first implant . The
distribution of the 14 pressure transducers has been Future Plans—A third prosthesis is underway. The
changed to include those locations on the femoral head major mechanical components are complete and fabrica-
which consistently reported data of interest as the subject tion will commence subsequent to implantation and
performed a wide range of movements and loading pat- completion of the early experiments with the second
terns. The mounting of the single-silicon-crystal canti- unit . During surgery, postsurgical management, and
lever beams, the flexion of which measures cartilage early rehabilitation, much data is acquired which
pressure, was changed . The first design called for epoxy requires the participation of all staff, with other tasks and
cementing, which exhibited cold flow and calibration assignments postponed.
deterioration on several of the transducers after several
years . An all-mechanical clamping technique was devised Implications—Data from the second and third pros-
and, extensively tested which eliminates this problem. theses will confirm the consistency of data across
This new arrangement also facilitates the precalibration subjects under similar experimental conditions.
adjustment of the beams relative to the pressure dia-
phragms and the interconnecting push-pins.
Separate in vitro studies of temperature rise by
"walking" human cadaver hip joints in the lip Simulator An Instrumented Endoprosthesis for Measuring Pressure on
Acetabular Cartilage In Vivo . Mann RW, Burgess RG, in
had indicated significant temperature rise . Subsequent Proceedings of the Workshop on Implantable Telemetry in
biochemical studies on chondrocyte response to these Orthopaedics, Berlin (in press) .
293
Orthopedic Implants
[368a] Rehabilitation Implications o In Vivo Hip

Pressure Measurements : Part 2
John A. McA . Harris, MD ; Robert W. Mann, ScD; W Andrew Hodge, MD

VA Medical Center, Jamaica Plain, MA 02130 ; Newman Laboratory for Biomechanics and Human Rehabilitation,
Mechanical Engineering Department, Massachusetts Institute of Technology, Cambridge, MA 02139;
Massachusetts General Hospital, Boston, MA 02114
Sponsor : VA Rehabilitation Research and Development Service (Project /1A352-2RA) ; National Institute on Disability and
Rehabilitation Research
Purpose—Surgical reconstruction or replacement of the Methodology—A pressure-instrumented prosthesis with

human hip joint following trauma or arthritis is a very 14 small sensors integral with the spherical, metal,
common occurrence, involving (in the United States pseudofemoral head measures the focal pressure experi-
alone) over four hundred thousand people each year . The enced by acetabular cartilage as it articulates against the
surgical procedures include total replacement of both femoral component . The first unit was implanted in June
femoral and acetabular components of the natural joint 1984. Data were acquired during surgery, postoperative
with artificial prostheses, replacement of only the recovery, immobilization, mobilization while in bed, early
femoral component (usually following femoral neck muscle exercise, all stages of ambulation (i .e., parallel
fracture), and osteotomies where the natural components bars, walker, crutches, and cane), and then during
of the joint are retained but realigned . Whatever the normal gait and other movement patterns such as rising
intervention, the patients must be managed during an from a chair, stair-climbing, jumping, and jogging, for a
immediate postsurgical period of immobility . They then total period of over 5 years . During movement protocols,
progress through a transitional process of rehabilitation the pressure data are complemented with six degree-of-
which takes them, in stages, through more demanding freedom kinematic data from the body segments of the
movement patterns, until they regain full capability and lower extremity and the pelvis, and the foot-floor forces
can perform other activities of daily living . The patient measured on dual forceplates . Very high local pressures
management and physical therapy protocols applied measured during certain movements indicate significant
throughout this process are essentially similar, whatever muscle cocontraction, which has been confirmed from
the particular hip surgery . Subjective generalizations concurrent electromyographic data from the major
derived from past experience with similar patients deter- muscle groups crossing the hip joint.
mine the optimum ordering, best postoperative time for The pressures measured during the various stages of
initiation, appropriate duration, and content of each recovery and rehabilitation are of direct relevance to the
protocol of these management and rehabilitation prac- evaluation of traditional rehabilitation procedures . Much
tices . Thus, protocols which are vital to the rapid, of the data demonstrates inconsistencies with what has
safe, and full recovery of the patient rest solely on been presumed to be meritorious and commonly accepted
qualitative observations and ex post facto outcomes. rehabilitation practice, both in ordering and timing . To
De novo quantitative objective data are now available cite several examples, most of the present immobilization
to evaluate these traditional processes and to consider practices produce higher maximum pressures than pedal-
alternatives. ing a stationary bicycle, a common early mobilization
procedure . Muscle contraction exercises performed in
Progress—Novel data from a pressure-instrumented bed, well before attempts at ambulation, produce pres-
femoral head replacement procedure have now provided sures of the same magnitude as those during the stance
objective, quantitative information on the mechanical phase of level walking measured a year postoperative.
environment of the human hip joint during surgery, Little correlation exists between the recorded maximum
postoperative management, throughout the process of pressures and the current sequence in ambulation therapy
rehabilitation, and in the activities of daily living . These (i.e., first parallel bars, then walkers, then crutches, then
data are challenging contemporary patterns of patient canes) . The measured hip pressure is little affected by the
care, therapy, and rehabilitation, and provide objective force applied to the partial-load-bearing cane . The maxi-
data on which to classify the strenuous character of many mum pressures measured during walking indicate no
normal and common movement patterns . further rise after 6 months, which correlated with the
294
clinical observation of achieving normal gait . The highest of implants has been proposed which would augment the
pressure measured was 18 MPa when rising from a pressure data with direct measurement of the force vector
normal (45 cm) chair . Astoundingly, this high pressure across, and the moments about, the hip joint.
is higher than that produced when a hydraulic jack lifts
a car.
Implications—This new quantitative pressure data can Contact Pressures from an Instrumented Endoprosthesis . Hodge
WA et al ., J Bone Joint Surg 71-A(9) :1378-1386, 1989.
provide the basis for a more rational definition of appro- Effects of Isokinetic and Isotonic Exercise on In Vivo Hip Contact
priate protocols applied during recovery and rehabilita- Pressure . Elbaum LE et al ., Transactions of the 35th Annual
tion following major hip surgery. The longitudinal data Meeting of the Orthopaedic Research Society, 225, 1989.
The Effects of Running and Gaining Weight in Comparison with
may explain why acetabular protrusion sometimes occurs Normal Gait on Pressures Measured in the Human Hip Joint.
following femoral head replacement . We believe the con- Harris CL et al ., in Proceedings of the 13th Annual Meeting
gruence of the metal ball to the natural acetabular cavity of the American Society of Biomechanics, Burlington, VT,
174-175, 1989.
—both diameter and geometry—is critical, as demon- In Vivo Hip Contact Pressures During Exercise and ADL . Krebs
strated in our in vitro studies . The new data are also influ- DE et al ., Phys Ther 69 :384, 1989.
encing surgical practice by indicating the directions of An Instrumented Endoprosthesis for Measuring Pressure on
maximum pressure ; accordingly, surgeons are using bone Acetabular Cartilage In Vivo . Mann RW, Burgess RG, in
Proceedings of the Workshop on Implantable Telemetry in
grafts to strengthen challenged regions of the pelvis. Orthopaedics, Berlin (in press).
In Vivo Pressures on Acetabular Cartilage Following Endoprosthesis
Future Plans—A second pressure-instrumented prosthe- Surgery, During Recovery and Rehabilitation, and in the Activities
of Daily Living . Mann RW, Hodge WA, in Proceedings of the
sis which incorporates a number of design improvements Workshop on Implantable Telemetry in Orthopaedics, Berlin
is ready for implantation . A future, more extensive series (in press).
[369] Optimized Surface Bonding and Stiffness

of Femoral Endoprostheses
Edward J . Cheal, PhD ; Myron Spector, PhD ; Robert Poss, MD ; Sarah Trilling; Balaji Ramamurti
Rehabilitation Engineering Research and Development, VA Medical Center, West Roxbury, MA 02132;
Brigham & Women's Hospital, Boston, MA 02115
Sponsor: VA Rehabilitation Research and Development Service (Project #A498-RA)
Purpose—Loosening of the femoral component is the which include Coulomb friction, are also employed in
most common complication of total hip replacement . The two-dimensional (2-D) models.
objective of this investigation is to determine the optimal
surface characteristics and material properties for a Progress—A 3-D finite element model of an intact femur
femoral endoprosthesis to avoid loosening . The specific was developed . This model was then modified to include
short-term objectives are to investigate the following a conventional straight-stem femoral component with a
design parameters using finite element modeling tech- collar for calcar contact. A third 3-D model was developed
niques: 1) the shape of the stem ; 2) a presence of a collar by replacing the straight-stem component with a contem-
for calcar contact ; 3) the surface distribution of bone- porary canal-filling femoral stem . Two large series of
prosthesis bonding for porous or ceramic coated stems; analyses were performed in which the area of bone-implant
4) the elastic modulus of the prosthesis ; and, 5) the role interface bonding was incrementally varied . Nonlinear
of Coulomb friction at the bone-prosthesis interface. gap elements were used at unbonded areas to simulate
frictionless contact . Separate analyses were performed
Methodology—This investigation employs computer- for cobalt-chromium, titanium, and carbon composite
based three-dimensional (3-D) structural models using implants . The applied loads represented three phases of
the finite element method . Iterative solution procedures, gait, stair ascent, and various isometric exercises.
based on mathematical optimization, are also being Most recently, a 2-D model of an axisymmetric stem
developed . New nonlinear contact surface algorithms, in diaphyseal bone was developed . This model included
295
Orthopedic Implants
nonlinear contact surfaces . Unlike the gap elements used region of bonding extended to the distal stem . The peak
in the 3-D models, these contact surfaces are capable of shear stress at the interface consistently occurred at the
large displacements and include Coulomb friction. distal edge of the bonded area . As the surface area of
Analyses are currently being performed of axisymmetric bonding was limited to proximal regions of the stem,
models and plane stress models with side plate elements large compressive interface stresses were predicted,
to evaluate various modeling techniques. which could exceed the strength of the supporting bone.
Results—The bone-prosthesis interface properties had a Future Plans—Our current objective is to apply various
strong influence on the stresses in the supporting bone. objective functions and constraints to determine the best
Cementing the femoral component resulted in the most distribution of bonding from the existing analyses . We
stress protection of the metaphyseal cortical and trabecu- will then make incremental changes and perform addi-
lar bone, followed by the fully-ingrown porous-coated tional analyses to determine the optimal solution . Several
implant, while the press-fit implant resulted in the least objective functions will be tested, including minimization
stress protection . In the more distal sections, the differ- of the stress differences between the intact femur and the
ences were small . The predicted stress protection in femur with the endoprosthesis, subject to constraints on
the metaphysis and proximal diaphysis agreed with pub- the shear stresses at the bone-implant interface . The 2-D
lished data. models will be completed in order to investigate the
The location of the maximum predicted interface relationships between Coulomb friction and subsidence
normal stress in the bone was highly dependent on the and micromotion.
region of interface surface bonding . It generally occurred
at the distal boundary of the bonded region, due to the
transfer of stress from the prosthesis to the bone.
However, the peak principal stresses in the cortical bone Parametric Analysis of the Interface Mechanics and Material
Properties of a Straight-Stem Femoral Component for Total
proximally, were not highly dependent on the amount of Hip Arthroplasty. Cheal EJ et al ., First World Congress of
surface bonding, and their magnitudes leveled off as the Biomechanics, 1990.
[370] Use of Proximal Femoral Allografts in 'rota Hip Revision
John P. Heiner, MD ; Ray Vanderby Jr, PhD ; Paul A . Manley, DVM ; Sean S. Kohles, MS ; Andrew A . McBeath
William S . Middleton Memorial VA Hospital, Madison, WI 53705 ; Division of Orthopedic Surgery,
University of Wisconsin, Madison, WI 53792
Purpose—Insufficient bone stock in the proximal femur interface for cemented versus press fit distal fixation) has
is a frequently encountered problem in revision hip been completed.
replacement, leading many surgeons to replace deficient
host bone with a proximal femoral allograft . A major Methodology—Ten large cadaveric canine femora were
problem, however, is establishing union between host used to simulate preoperative and acutely postoperative
femur and allograft . A nonunion rate of 10% has been conditions . Allografts were simulated with proximal
reported with cemented fixation . If the distal stem is femoral autografts, making the bone graft ideally sized.
press fit into the host bone, substantially different Femoral components were press fit into each medullary
mechanics would likely occur at the allograft-host bone canal . Three stacked rosette strain gages and three eddy
interface, differences which may enhance their union. current transducers (ECTs) were adhesively bonded to
The purpose of this study is to compare these alternative the bone, measuring strains near the allograft-host bone
methods of distal stem fixation when used with a prox- interface and relative displacements of the allograft,
imal femoral allograft in total hip replacement. respectively. Axial loads and transverse loads (torsion
producing) were applied to the femoral (or implant) head.
Progress—The first phase of this project (an ex vivo Testing on each femur was performed in the follow-
study comparing mechanics at the allograft-host bone ing sequence : 1) control (intact femur) ; 2) press fit femoral
296
implant (no graft) ; 3) femoral implant cemented to prox- at least one ECT for at least one loading condition . The
imal autograft and press fit distally ; and, 4) femoral transverse ECT typically measured relative displacements
implant cemented proximally and distally . From the greater than 1 mm for both axial and transverse loadings.
strain gage data, principal strains and strain energy
densities (SED) were calculated. Future Plans/Implications—Cemented distal fixation
provides a stable structure for allograft augmented total
Results—As a general trend, maximum compressive hip revisions, but it reduces the load transfer at the
principal strains decreased as the testing sequence allograft-host bone interface, when compared with a distal
progressed for axial loading cases . A similar behavior press fit . This decreased load transfer may contribute
was observed with SEDs . In each case, the cemented to nonunions . The alternative of a distal press fit was un-
group consistently produced the lowest absolute strain. stable in at least one mode of loading in our experiments.
This effect was significant in all minimum principal The design of the distal stem used in this study probably
strain comparisons at two of the three rosette locations. contributed to this instability . If stability can be obtained
For torsional loads, the absolute strain in the cemented with an alternative (press fit) stem design, load transfer
group was always smaller than the press fit group. advantages may exist at the host bone-allograft interface.
The distally cemented group had small relative dis- Therefore, an alternative design for the distal stem was
placements of the allografts . In contrast, each specimen formulated . This design is currently being manufactured
in the press fit group had high relative displacements in and will be used in future in vivo canine studies.
[371] Dynamic Implant for the Development of

a Cementless Prosthesis
I .L. Kamel ; R . Seliktar; F. Ko ; A .N. Sharda

The Biomedical Engineering and Science Institute, Drexel University, Philadelphia, PA 19104
Purpose—The aim of this project is to develop a biocom- Braid Design . Selection of braiding parameters is
patible material with a range of mechanical properties necessary to achieve the required degree of base-polymer
similar to those of human compact bone . The ultimate reinforcement. The braid angle, the type and volume
goal is to use the new material as cementless prostheses, fraction of fibers, and the degree of fiber packing
for example, joint implants. (beat-up) are optimized to provide a high level of com-
pressive strength while retaining the high tensile strength
Progress/Methodology—The general composition of inherent in braided structures.
this dynamic implant is a hydrophilic, crosslinked matrix Polymer Systems . Two different crosslinking agents
reinforced with a three-dimensional (3-D) braided fiber are blended with the base monomer (acrylic acid) prior
structure . The stages of the development of the material to its polymerization . The first crosslinking step occurs
system include the design and use of 3-D braid to achieve by a free radical mechanism during polymerization,
the desired degree of structural reinforcement ; the selec- while the second step involves using glycerol in a conden-
tion of a candidate material for use as the matrix polymer sation reaction to be completed in the solid state by a
base ; formulation and optimization of the composition postpolymerization heat-curing cycle which induces ester
and the crosslinking scheme of the base polymer ; devel- bond formation between the glycerol and the pendant
opment of a mechanical model to represent and predict acid groups in the matrix . Formation of the ester bonds
the behavior of the composite structure under load; is used as a final control on the resulting equilibrium
verification of the analytical prediction by testing pressure and is measured using TGA and FTIR tech-
the mechanical properties of the neat polymer and the niques which are currently in progress.
polymer/braid-reinforced composite ; and, evaluation Mechanical Testing and Evaluation. The crosslinking
of the interfacial pressure level to be utilized for in-situ reaction of glycerol enhances polymer strength and modu-
implant fixation . Progress in each of these areas is dis- lus. However, unreacted glycerol acts as a plasticizer,
cussed below. lowering the same properties . To date, the mechanical
297
Orthopedic Implants
properties of the neat resin have remained significantly taken into consideration . The procedure to determine the
below those of compact bone . When a fiber network is geometry and mechanical properties requires an initial
introduced in the above system, it enhances both the postulation of a set of mechanical parameters . The
strength and modulus of the matrix, and brings these braided geometry is then estimated by minimizing
properties within the target range for compact bone. the total strain energy, or employment of the Tsai-Hill
Evaluation of Interfacial Pressure . The interfacial yield criteria . Currently, attempts are being made to
pressure between the implant and surrounding bone is estimate the overall stresses due to swelling of the hydro-
used to affix and hold the structure in place and acceler- philic matrix.
ate bone response and densification . Thus, radial stresses
are being measured as a function of time using cylindrical Recent Publications Resulting from This Research
specimens incubated in Ringer's solution, while fitted in
A Dynamic Implant for the Development of a Hip Stem Prosthesis.
a metallic mold of the same size as the dry sample. Sharda AN, Kamel IL, presented at the Annual Conference of
Development of a Finite Element Model . In the the IEEE Engineering in Medicine and Biology Society,
present analysis, a 3-D orthotropic braided structure is Philadelphia, 1990.
[372] Correlation of In Vivo Synovial Joint Pressure Data with that from
Posthumous Hemipelvis and Proximal Femur Including
Pressure-Instrumented Endoprosthesis
Robert W. Mann, ScD ; John A . McA. Harris, MD

Newman Laboratory for Biomechanics and Human Rehabilitation, Mechanical Engineering Department,
Massachusetts Institute of Technology, Cambridge, MA 02139 ; VA Medical Center, Jamaica Plain, MA 02130
Sponsor : Whitaker Foundation, Health Sciences Fund
Purpose—Only one pressure-instrumented femoral head pressure calibration can proceed . Calibration of the effect
prosthesis has ever been implanted ; that prosthesis has of temperature on pressure sensor output has also begun.
been retrieved posthumously together with the proximal The techniques for obtaining acetabular geometry
femur and hemipelvis . Data was acquired from this measurements are being tested prior to application on the
prosthesis for a broad spectrum of activities and positions excised acetabulum . Static tests in the Hip Simulator, a
throughout the five years that it was implanted . This multi-axis, electrohydraulic testing facility will follow,
extensive array of in vivo data can now be compared with followed by dynamic experiments with the Hip Simulator
in vitro data that can be taken during comparable experi- under computer control.
ments in the laboratory. In vitro experiments afford con-
trol over experimental conditions which are not possible Implications—Correlation of in vivo and posthumous in
in vivo, and which will assist in further interpretation of vitro data will permit confident quantification of the
in vivo data. Evaluation of the state of the acetabular car- forces experienced at the hip joint in life . This informa-
tilage following five years of contact with a well-matched tion and the knowledge gained from the acetabular mea-
femoral head replacement will also provide information surements are expected to influence the design of femoral
never previously obtained and relevant to longevity of this head replacements and surgical procedures, both of
orthopaedic procedure. which involve endoprosthesis and total joint replacement.
Methodology—Hardware required for high-pressure Recent Publications Resulting from This Research
calibration of pressure sensors in the prosthesis has been
Optical Verification of a Technique for In Situ Ultrasonic Measure-
built and tested . Software for acquisition of data from the ment of Articular Cartilage Thickness . Modest VE, Murphy
prosthesis is functional on a personal computer ; thus, MC, Mann RW, J Biomech 22(2) :171-176, 1989.
298
[373] Synovial Joint Biomechanics and the Pathogenesis

of Osteoarthritis
Robert W. Mann, ScD

Newman Laboratory for Biomechanics and Human Rehabilitation, Mechanical Engineering Department,
Massachusetts Institute of Technology, Cambridge, MA 02139
Sponsor : Whitaker Foundation, Whitaker Professorship of Biomedical Engineering, Newman Laboratory Fund
Purpose—Osteoarthritis, or degenerative arthritis, dis- five years of in vivo data. We plan to both replicate in vivo
ables more Americans than any other disease, producing experiments and perform tests not feasible in life.
much pain and loss of mobility while causing the greatest
loss of worker productivity . This project is exploring how Results—Computer simulations of the human hip synovial
the human hip joint accommodates the forces and dis- joint and correlating experimental data confirm the role
placements of normal movement, and whether, and how, of the interarticular seal in maintaining the high pres-
these mechanical factors contribute to the pathogenesis of sures, which for a healthy joint carrier, are typically
osteoarthritis, either directly or by affecting the biology more than 90% of the load . The degeneration of this seal
of cartilage. is, we believe, tantamount to osteoarthritis . Accordingly,
we are focusing on understanding the nature of this
Methodology—The in vitro phase of the investigation remarkable resistance to fluid flow . The cartilage-to-
involved analysis and experiment on human hips from cartilage spacing in synovial joints in life is thought to be
cadavers and the development of a detailed mathematical very small, but has never been measured.
model of the cartilage and bone in this ball-and-socket A feasibility study of a technique to measure the
synovial joint . Results include interarticular surface interarticular gap using ultrasound has been carried out.
stress and strain, fluid exuded/imbibed, fluid pressures Theoretical analyses for the experiments, the instrumen-
and the interarticular flow paths, solid matrix friction, tation, digital signal processing algorithms, and experi-
entropy generation, and consequent temperature rise. mental techniques, have been developed and applied to
The in vivo phase includes five years of unique pres- the measuring technique with encouraging results. New
sure data from the human hip (see "Rehabilitation ultrasonic instrumentation to be installed in a pseudo
Implications of In Vivo Hip Pressure Measurements," femoral-head prosthesis, in order to measure in vitro the
pp . 291-294) . We now also have the unique opportunity global distribution of clearance between the prosthesis
to study in vitro the acetabulum and the pressure- and the natural cartilage of the pelvis of a hip joint, has
instrumented endoprosthesis from which we acquired our been designed.
C. Knee
[374] All-Plastic Total Knee Replacement
Myron Spector, PhD ; Edward J . Cheal, PhD ; Frederick Ewald, MD ; Ed Wachtel

VA Medical Center, West Roxbury, MA 02132 ; Brigham and Women's Hospital, Boston, MA 02115
Sponsor : VA Rehabilitation Research and Development Service (Project #A217-3RS)
Purpose—Greatly altered distribution of strain in bone Our overall goal is to develop a total knee
surrounding metallic total joint replacement prostheses replacement made entirely from polymeric material
can lead to a net decrease in bone density, and an adverse (including fiber-reinforced polymeric composites) . A
biological response might be elicited by metal ions specific objective is to test the hypothesis that a more
released from the device . compliant polymeric total knee replacement prosthesis
299
Orthopedic Implants
leads to more physiological remodeling of underly- a laser light-scattering device and by scanning electron
ing bone. microscopy. The results of the wear debris analysis are:
1) porous PSF, size = 8.09 pm, SD = 3 .37; 2) PSF, size
Methodology—A radiographic evaluation of metallic = 6.96 /AM, SD = 3 .59 ; 3) textured PEEK, size = 22.67
total knee replacement prostheses in humans was under- j.m, SD = 10 .1; 4) smooth PEEK, size = 8.04 pirn, SD =
taken to determine the prevalence of bone loss that might 4.81 ; and, 5) carbon-reinforced PEEK with perpendicular
be due to the high stiffness of the device . This would orientation, size = 10 .44 pm, SD = 5 .19 . Statistically
serve as rationale for the development of an all-plastic meaningful results were unobtainable for the titanium,
total knee replacement prosthesis . The tribological perfor- UHMWPE, PMMA, and the carbon fiber-reinforced
mance of candidate polymeric materials is being assessed PEEK composite with parallel orientation . The size dis-
in a laboratory apparatus designed to evaluate various tribution for porous PSF and the bulk PSF were com-
combinations of polymer-polymer articulation . Another pared using an unpaired, two-tailed Student's t-test . No
apparatus is evaluating the morphology and size of wear statistically significant difference was found to exist
particles that are produced as candidate biomaterials are between the two materials . Results for the two different
abraded against bone (as might occur if the all-plastic PEEK materials indicate that the particle size of the wear
knee prosthesis is employed as a cementless device). debris is much larger for the textured material than for
Prototype polymeric total knee replacement prostheses the smooth . The two distributions were compared using
are being designed for implantion in dogs to evaluate an unpaired, two-tailed Student's t-test, with the result
tissue response. being significant at the p < 0.0001 level . Debris from the
UHMWPE material exhibited a large aspect ratio (30 :1).
Progress —In a retrospective radiographic review of 147 The particles were 10 to 15 /AM in diameter. There were
total knee arthroplasties, bone loss was found to occur in insufficient numbers of particles to determine the average
a distal anterior femur in 68% of the cases reviewed . The size statistically . The isolated titanium particles have a
prevalence of bone loss was independent of mode of fixa- plate-like morphology with a thickness of 5 to 10 pm.
tion (porous-coated versus cemented) and the implant The wear-tracks in the bone counterface materials were
design. Radiographically detectable bone loss occurred examined using a depth-indicating device . The results for
within the first postoperative year and did not progress the parallel and perpendicular composite materials
further. Three-dimensional finite element analysis per- showed a large difference . The perpendicular material
formed by other investigators has demonstrated that the produced a wear-track that was larger by an order of
replacement of the bearing surface of the femur with a magnitude . The cause for this difference is believed to
stiff metallic implant reduces the stress in the distal be fiber orientation . Delamination occurs in perpendicu-
anterior femur by at least one order of magnitude . We lar fiber orientation (as seen on the wear pin face),
conclude that the bone loss resulted from stress shielding. resulting in debris generation and an abrasive wear
One series of wear studies employed a six-channel mechanism . In contrast, the parallel orientation shows no
pin on flat wear-test machine-abraded candidate poly- delamination and the wear-track results are similar to
mers against cortical bone slabs . The polymer specimens those of bulk PEEK.
included: ultrahigh molecular weight polyethylene A second wear apparatus comprises four
(UHMWPE), polymethylmethacrylate (PMMA), poly- pneumatically-driven cylinders capable of applying
etherether ketone (PEEK) with smooth and textured physiological loads to specimens sliding on flat plates
surfaces, carbon-reinforced PEEK composite in parallel in a reciprocating motion . This machine determines
and perpendicular orientations, and polysulfone (PSF) in the function and wear characteristics of polymer-
bulk and porous form . Titanium alloy served as the con- polymer bearings.
trol. The operating conditions were : applied stress = 0.22
MPa, sliding speed = 24 mm/sec, temperature = Future Plans—A design project is underway to develop
ambient, lubricant = distilled water, duration = 32,000 prototype composite femoral condylar prostheses for
cycles . Particles collected after testing were analyzed using implantation into dogs .
300
[375] Articular Cartilage Replace en Prosthesis

for the War-Injured and Aging
Myron Spector, PhD ; Edward J. Cheal, PhD ; Gregory Brick, MD ; Ed Watchel

VA Medical Center, West Roxbury, MA 02132 ; Brigham and Women's Hospital, Boston, MA 02115
Purpose—Left untreated, focal defects in articular car- of inflammatory agents including prostaglandin E 2 ,
tilage produced by excessive joint loading can grow to the interleukin-1 and interleukin-6 are being evaluated using
extent that they lead to degeneration of the entire joint, radioimmunoassays.
and the need for total joint replacement, The objective of An animal model is being developed to evaluate the
this investigation is to develop a prosthesis that can efficacy of the articular cartilage replacement prosthesis
replace these focal defects in articular cartilage . In its (ACRP) . Cylindrical holes drilled in the patella of dogs
initial form, this prosthesis would be a cylindrical implant are to serve as the test sites for evaluating the perfor-
inserted into holes drilled through the articular cartilage mance of candidate ACRP constructs.
defects. The device would have a polymeric surface
which would be capable of articulating against the appos- Progress—The fabrication of ACRP constructs has been
ing natural articular cartilage without causing accelerated accomplished by bonding elastomers (e .g., silicone and
degeneration of that or surrounding tissue. polyurethane) to a porous thermoplastic (e .g., poly-
sulfone) substrate, which is to serve as the attachment
Methodology—One task is to investigate the tribology of vehicle to bone . Mechanical testing is being performed
candidate materials to be employed for the articulating to compare the mechanical properties of the ACRP
surface of the device . In a tribological apparatus, natural constructs with certain properties of natural articu-
articular cartilage specimens are being rubbed against lar cartilage.
candidate polymeric substances . The coefficient of fric- Cell culture assessment of the relative "biocompati-
tion and the degradative changes of the articular cartilage bility" of candidate polymers has revealed elevated levels
are being determined. of IL-1, IL-6, and PGE2 produced by monocytes cultured
Another task has been to develop a method to assess on ultrahigh molecular weight polyethylene . Other
the "biocompatibility" of candidate polymeric materials polymers are undergoing evaluation.
to be employed for this application . Human peripheral A surgical procedure for implanting ACRP constructs
blood monocytes, obtained from human volunteers, are into the dog patella has been developed . Animal implan-
being cultured on polymeric substrates . The production tation is underway.
[376] Improved Anchorage of Knee Replacements Based on

Confirmed Design Rules
Edward W. Berg, MD ; Elin Barth, MD, PhD ; R . Larry Dooley, PhD ; Gunther Heimke, PhD ; Dennis L . Powers
William Jennings Bryan Dorn VA Hospital, Columbia, SC 29201 ; University of South Carolina School of Medicine,
Columbia, SC 29209 ; Clemson University, Clemson, SC 29634-0905
Sponsor: VA Rehabilitation Research and Development Service (Project #A546-RA)
Purpose—The goal of the proposal is to develop a tibial Progress—We have developed a tibial stem with a surface
component of an artificial knee joint for fixation by design intended for cementless fixation by osseointegra-
osseointegration . It has long been known that the tion . To date the prototype of the total knee replacement
anchorage of the tibial component in human knee has been manufactured using computer-aided design and
implants tends to fail whether a cemented or a porous- machining based on the dimensions of dog knee X-rays.
coated design is used . In fact, loosening of the tibial A cemented femoral stem with a hinge is attached to the
component is the most frequent single cause of failure in uncemented, "press-fit" tibial component . A total of four
total knee replacement . titanium knee joint prostheses have been implanted in
301
Orthopedic Implants
short-time survival dogs . One prosthesis has recently be evaluated by mechanical testing of the strength of
been implanted in a long-term survival dog . At present, fixation of the bone-implant interface and by histomorpho-
histomorphometry equipment and the pertaining software metric analysis.
for analysis of the efficacy of osseointegration at the bone
implant interfaces are being tested . The system was oper- Future Plans/Implications—The first 15 knees were im-
ational by the end of September, 1990. planted by the end of December 1990 . It is anticipated that
the remaining 25 knees will be implanted by July 1991.
Methodology—The design will be tested in 40 dogs to be The mechanical and histomorphometric evaluations will
sacrificed at specific time intervals (1, 2, 4, and 8 be completed in December 1991 . If successful, the design
months) postoperatively . The implant performance will may form the basis for the development of human implants .

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Journal of Rehabilitation Research and Development

Rehabilitation R & D Progress Reports 1990

XI. Orthopedic Implants

[353] Percutaneous Prosthetic Limb Attachment

Edmund B. Weis, Jr., MD

[354] Fracture Healing and Bone Remodeling in Plated Long-Bones

Gary S. Beaupre, PhD ; Dennis R. Carter, PhD ; John Csongradi, MD

Rehabilitation R & D Progress Reports 1990

[355] Bone Ingrowth and Remodeling with Porous Coated Implants

[356] High Viscosity Cooler Acrylic Bone Cement

Rehabilitation R & D Progress Reports 1990

[357] Effects of Treatment for Heterotopic Bone Formation

[358] Effect of Surgical it on the Biological and Mechanical Response

Rehabilitation R & D Progress Reports 1990

[359] Optimization of Orderly Oriented Wire Mesh

[360] Evaluation and Examination of Retrieved Porous-Coated

Rehabilitation R & D Progress Reports 1990

[361] Surface Failure in UHMWPE Joint Components

[362] Cell Response to Modified Ti Surfaces (Rats)

[363] Titanium and Ti-6A1-4V Alloy Implant Fabrication (Rabbits)

Rehabilitation R & D Progress Reports 1990

[364] Ion Sputter Deposition of Ca-P Thin Films

Linda C. Lucas, PhD ; William R . Lacefield, PhD

[365] Ion I mplantation to Reduce Wear on Polyethylene Prosthetic Devices

Rehabilitation R & D Progress Reports 1990

[366] Epiphyseal Hip Replacement : A Pilot Study

Dennis R . Carter, PhD ; Tracy E . Orr, PhD

[367] Quantitative Analysis of Total Hip Arthroplasty

Gary J . Miller, PhD ; Donna Wheeler, MS ; R . William Petty, MS, MD

[368] Rehabilitation Implications of In Vivo Hip

John A. McA. Harris, MD ; Robert W. Mann, RD

Sponsor : VA Rehabilitation Research and Development Service (Project #A352-2RA)

Rehabilitation R & D Progress Reports 1990

[368a] Rehabilitation Implications o In Vivo Hip

John A. McA . Harris, MD ; Robert W. Mann, ScD; W Andrew Hodge, MD

Purpose—Surgical reconstruction or replacement of the Methodology—A pressure-instrumented prosthesis with

Rehabilitation R & D Progress Reports 1990

[369] Optimized Surface Bonding and Stiffness

[370] Use of Proximal Femoral Allografts in 'rota Hip Revision

Rehabilitation R & D Progress Reports 1990

[371] Dynamic Implant for the Development of

I .L. Kamel ; R . Seliktar; F. Ko ; A .N. Sharda

Robert W. Mann, ScD ; John A . McA. Harris, MD

Rehabilitation R & D Progress Reports 1990

[373] Synovial Joint Biomechanics and the Pathogenesis

Robert W. Mann, ScD

[374] All-Plastic Total Knee Replacement

Myron Spector, PhD ; Edward J . Cheal, PhD ; Frederick Ewald, MD ; Ed Wachtel

Rehabilitation R & D Progress Reports 1990

[375] Articular Cartilage Replace en Prosthesis

Myron Spector, PhD ; Edward J. Cheal, PhD ; Gregory Brick, MD ; Ed Watchel

[376] Improved Anchorage of Knee Replacements Based on

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