MG Sturznickel
MG Sturznickel
Injury
journal homepage: www.elsevier.com/locate/injury
a r t i c l e i n f o a b s t r a c t
Article history: Aims: Biodegradable magnesium-based alloy implants represent a promising option in orthopedic
Accepted 15 March 2021 surgery, as the clinical outcomes have been reported to be comparable to those of titanium implants
Available online xxx
and no surgical interventions are required for removal. To date, little is known about the results of the
Keywords: use of these implants in children and adolescents. Therefore, the aim of the present study was to analyze
Magnesium screws the safety and performance of these implants in children and adolescents.
Pediatrics Patients and Methods: Eighty-nine patients treated with magnesium-based implants for fracture stabi-
Osteosynthesis
lization, osteotomy and osteochondral refixation were analyzed; 38 were treated by osteosynthesis; 18,
Osteotomy
Osteochondral refixation
osteotomy; and 33, osteochondral refixation. The mean follow-up duration was 8.2 months (range, 1.5–
30 months). Clinical and radiographical follow-up examinations were performed at 4–8 weeks and 3–6
months, respectively, to evaluate implant performance and osseous consolidation.
Results: Clinical outcomes were rated as good to very good in all patients. Radiolucent zones were appar-
ent after surgery in all patients but were noted to decrease in size during the follow-up period. Revision
surgery was necessary in 1 of 89 patients who had a highly unstable osteochondritis dissecans lesion of
the knee. None of the magnesium-based implants required surgical removal.
Conclusion: Magnesium-based implants in children and adolescents results in good clinical outcomes
when used for fracture stabilization, osteotomy and osteochondral defect refixation. Future studies are
needed to further analyze the significance of the transient appearance and temporal development of ra-
diolucent zones in the growing skeleton as well as the long-term performance of these implants.
© 2021 Elsevier Ltd. All rights reserved.
Introduction duction, optimal stability, and successful fracture healing and avoid
long-term complications, such as nonunion or posttraumatic os-
While 10–25% of injuries per year in children and adolescents teoarthritis. In contrast to adults, in school-aged children, the use
can be attributed to fractures, an annual fracture incidence of of elastic nails and Kirschner wires is common for treating frac-
160/10,0 0 0 has been reported [1-3]. Compared to adults, children tures [5], indicating that comparably less implant stiffness and fix-
and adolescents have a more adaptable skeleton, with a greater ation are required for successful fracture healing in general. Espe-
regenerative capacity, resulting in excellent overall osseous heal- cially in children and adolescents, there is a trend toward less in-
ing and low rates of delayed union or pseudarthrosis [4]. However, vasive surgical techniques [5-7]. However, implant removal is gen-
osteosynthesis may be necessary to achieve adequate fracture re- erally recommended for all implants in children and adolescents
by the current national guideline [8]. Therefore, biodegradable im-
plants may be particularly applicable and useful for selective indi-
∗
Corresponding author.
cations in this patient group.
∗∗
Co-corresponding author at: Department of Pediatric Orthopaedic Surgery, Chil- In recent years, biodegradable magnesium-based implants have
dren’s Hospital Hamburg-Altona, Bleickenallee 38, 22763 Hamburg, Germany. been increasingly used in orthopedic surgery in adults [9-11]. The
E-mail addresses: Michael.Kertai@barmherzige-regensburg.de (M. Kertai), degradation of magnesium-based implants is a galvanic corrosion
Martin.Rupprecht@kinderkrankenhaus.net (M. Rupprecht).
https://doi.org/10.1016/j.injury.2021.03.037
0020-1383/© 2021 Elsevier Ltd. All rights reserved.
Please cite this article as: J. Stürznickel, M.M. Delsmann, O.D. Jungesblut et al., Safety and performance of biodegradable magnesium-
based implants in children and adolescents, Injury, https://doi.org/10.1016/j.injury.2021.03.037
JID: JINJ
ARTICLE IN PRESS [m5G;March 25, 2021;20:15]
J. Stürznickel, M.M. Delsmann, O.D. Jungesblut et al. Injury xxx (xxxx) xxx
process that releases hydrogen gas [12]. The major advantage of classified as MgYREZr (i.e., magnesium, yttrium, zirconium and
these implants is that additional surgery for implant removal is other rare earth metals) alloys according to DIN EN 1753. The
no longer required. By using magnesium-based implants, the mor- double-threaded MAGNEZIX® CS compression screw is available
bidity and possible complications of a second surgery [13] are with diameters of 2.0, 2.7, 3.2 and 4.8 mm, each with varying
avoided. Previous studies have assessed the surgical outcomes of length options. One special characteristic of the 4.8-mm screw
magnesium-based screws for different indications, demonstrating (MAGNEZIX® CSC 4.8) is that the ceramic surface delays corrosion
promising results [11,14]. Other studies have tested the biome- in the first month compared to the smaller sizes. The MAGNEZ-
chanical characteristics, revealing properties more analogous to IX® pin is available with diameters of 1.5, 2.0, 2.7 and 3.2 mm and
those of bone than those of comparable titanium implants [15]. lengths of 8–50 mm (increments of 2 mm).
The successful implantation of magnesium-based implants in ado- The MAGNEZIX® CBS screw has a typical cortical screw design.
lescents with osteochondral defects was recently shown by our The surgical technique and instrumentation of the MAGNEZIX®
group [16]. CBS screws are comparable to those of conventional implants made
The aim of the present study was to investigate the safety and of steel or titanium. The threads of the head and the shaft have dif-
performance of biodegradable magnesium-based implants (MAG- ferent thread pitches, generating compressive forces supporting in-
NEZIX® CS or CBS screws and MAGNEZIX® pins, Syntellix AG, terfragmentary compression. The MAGNEZIX® screws are not self-
Hannover, Germany) for selected indications (fracture fixation, os- drilling but are self-cutting. Therefore, the screw hole needed to be
teotomy and osteochondral defect refixation) in children and ado- predrilled during the operation to avoid weakening of the implant.
lescents. In contrast, the MAGNEZIX® CSC 4.8 screw is cannulated, allow-
ing the usage of a guide wire, which was inserted via the drill
Materials and methods guide system and is a few millimeters longer than the selected
screw. This prevents the guide wire from being completely drilled
Study design off during the subsequent drilling process. The length of the screw
was determined, and predrilling was performed. To simplify inser-
All patients under 18 years of age who were treated between tion of the screw head, the head side was reamed using a counter-
04/2018 and 04/2020 with magnesium-based screws (MAGNEZIX® sink with the guide wire still in place. Finally, MAGNEZIX® CSC 4.8
CS or CBS screws) or magnesium-based pins (MAGNEZIX® pins) screw was positioned using the inserted guide wire.
(i) for fracture fixation, (ii) osteotomy, or (iii) osteochondral de- MAGNEZIX® pins were used during standard arthroscopy in
fect refixation and met the inclusion criteria were included in this cases of patellar luxation and/or OD. After reduction of the dis-
analysis after informed consent was obtained from the patients or placed fragments (in some cases, reduction wires were used for
the respective legal representatives. The end point of this study temporary stabilization), predrilling of the implant bed was per-
was successful healing of the fractures, osteotomies and osteochon- formed with the drill bit. Subsequently, the depth of the drilled
dral lesions as assessed by radiological examination. In addition, hole was determined with a depth gage to determine the required
the performance on follow-up, rate of complications, and number length, and a pin was then carefully impacted into the pilot hole
of surgical revisions were assessed. Preoperative imaging (X-ray, with the aid of a hammer while under protection by the impactor.
magnetic resonance imaging (MRI) or computed tomography (CT)) All pins were countersunk under the chondral surface to avoid
findings were used to assess the underlying pathologies and con- prominent protrusion.
firm the surgical indications. All patients returned for clinical and As magnesium-based implants undergo a degradation process,
radiographical follow-up examinations after 4–8 weeks and 3–6 with decreasing mechanical stability over time, axial deviation was
months. Furthermore, some patients returned for additional exam- not generally judged as implant failure. Accordingly, implant fail-
inations according to routine clinical practice, exceeding the mini- ure was defined as axial deviation observed without signs of im-
mum follow-up period of 3–6 months. At follow-up examinations, plant degradation, leading to nonhealing and the need for revision
X-rays and/or MRI scans were used to verify correct positioning of surgery.
the screws as well as determine radiographic healing of the lesions.
All patients were treated by an attending surgeon (three different Statistical analysis
senior surgeons). The postoperative regimen was not different from
that after surgeries performed with regular implants. Walking with Statistical analysis was performed using GraphPad Prism ver-
full weight-bearing and active exercises started after six weeks, if sion 8.4.0 software (GraphPad Software, Inc., USA). The results
applicable, and after confirmation of sufficient bone healing as de- are presented as absolute values or the mean ± standard devia-
termined by radiography. tion (SD). The normal distribution of the data was tested by the
Intra- and postoperative complications, such as fractures, im- Shapiro-Wilk test. The Kruskal-Wallis test with Dunn’s multiple
plant breakage, delayed union and nonunion, were documented. comparison test was applied for nonparametric data. The level of
Postoperative radiological outcomes (fracture consolidation and os- significance was defined as p<0.05.
seous integration) were documented at the follow-up visits. Fur-
thermore, clinical success was defined as complete restoration of Results
the clinical and functional status (full range of motion, no se-
vere pain, and full function within activities of daily life and Patient characteristics
sports/performing arts). This retrospective study was conducted
with approval from the local ethics committee (Ethikkommission In this study, 89 patients (45 females, 44 males; age, 12.9 ± 3.2
Ärztekammer, Hamburg, WF-075/20). years; BMI, 21.9 ± 4.9 kg/m2 ; Table 1) who received biodegrad-
able magnesium-based implants were included. Of the 89 patients,
Implants and surgical procedure 38 underwent fracture fixation (i.e., osteosynthesis, OS), 18 under-
went osteotomy or the Elmslie-Trillat procedure (OET), and 33 pa-
Implants with specific dimensions were used according to the tients underwent osteochondral lesion refixation (RFix) (Fig. 1A,
individual requirements. MAGNEZIX® CS or CBS screws and MAG- Table 1). Patients in the OS (11.5 ± 3.9 years) and RFix groups
NEZIX® pins (Syntellix AG, Hannover, Germany) are CE-certified (13.4 ± 2.1 years) were significantly younger than patients in the
aluminum-free magnesium alloy screws and pins, respectively, OET group (15.1 ± 1.3 years; OS vs. OET, p<0.0 0 01; RFix vs. OET,
2
JID: JINJ
ARTICLE IN PRESS [m5G;March 25, 2021;20:15]
J. Stürznickel, M.M. Delsmann, O.D. Jungesblut et al. Injury xxx (xxxx) xxx
Table 1
Patient characteristics. Demographic characteristics of all patients and the respective sub-
groups (osteosynthesis, OS; osteotomy or Elmslie-Trillat procedure, OET; osteochondral re-
fixation, RFix), including sex distribution, age and BMI.
f – female; m – male.
a
p<0.05 for osteosynthesis vs OET.
b
p<0.05 for OET vs RFix.
Fig. 1. Overview of the presented surgeries and the included patient cohort. (A)
Osteosynthesis (OS) represented most of the performed implantations, followed by
osteochondral refixations (RFix) and osteotomies/Elmslie-Trillat (OET). (B) Age dis-
tribution in the three subgroups revealing that the patients receiving OET were
significantly older. (C) Number of surgeries performed at the different anatom-
ical localizations. OS – osteosynthesis; RFix – osteochondral refixations; OET –
osteotomies/Elmslie-Trillat; yrs – years.
3
JID: JINJ
ARTICLE IN PRESS [m5G;March 25, 2021;20:15]
J. Stürznickel, M.M. Delsmann, O.D. Jungesblut et al. Injury xxx (xxxx) xxx
Table 2
Implant performance. The number of individuals, the follow-up period, the total number of implants and the number of cases of implant fail-
ure (defined as nondegradation-associated axial deviation of the implant and loss of function) with the number of required revision surgeries
are provided.
Individuals (n) Follow-up (months) Implants (n) Intraop. compl. Implant failure (n) Revision surgery (n)
Table 3
Implant performance grouped by the most common sites. The number of individuals who underwent surgery were further divided by the use of
screws and pins, as well as the most common indications, if applicable. The follow-up period, the total number of implants, the number of cases of
implant failure (defined as nondegradation-associated axial deviation of the implant and loss of function) and the number of required revision surgeries
are provided.
Individuals (n) Follow-up (months) Implants (n) Intraop. compl. Implant failure (n) Revision surgery (n)
4
JID: JINJ
ARTICLE IN PRESS [m5G;March 25, 2021;20:15]
J. Stürznickel, M.M. Delsmann, O.D. Jungesblut et al. Injury xxx (xxxx) xxx
Discussion
Fig. 4. Representative images of osteotomy or Elmslie-Trillat procedure (OET) with magnesium-based alloy screws. The patient presented with patellar luxation and
post-traumatic contusion of the distal femur indicated by bone marrow edema in MRI (left panel). The axial view represents patellofemoral malalignment. Consequently,
Elmslie-Trillat procedure was performed with two MAGNEZIX® CSC 4.8 screws. Note the intermittent presence of radiolucent zones (2nd from right panel), as well as the
visible degradation of the screw head at the 1-year follow-up (right panel, arrow indicating the screw head degradation process).
d – day; w – weeks; yr – year.
5
JID: JINJ
ARTICLE IN PRESS [m5G;March 25, 2021;20:15]
J. Stürznickel, M.M. Delsmann, O.D. Jungesblut et al. Injury xxx (xxxx) xxx
Fig. 5. Representative images of osteochondral defect refixation with magnesium-based alloy pins. A prominent osteochondritis dissecans of the talus was detected in
MRI (left panel), which was fixed with MAGNEZIX® 2.0 pins (middle panel, arrows indicating implants). Follow-up evaluation after 6 months revealed osseous integration
of the defect (2nd from right panel). Successful consolidation of the former defect and degradation of the magnesium-based implants was observed after 15 months (right
panel).
m – months.
surgery and impair the quality of life of the treated patients. An- Conclusion
other important finding of this study was that the implantation
of both titanium Kirschner wires and magnesium-based screws in To the best of our knowledge, this is the first study assessing
close proximity did not result in a significant acceleration of corro- the clinical safety and successful use of biodegradable magnesium-
sion kinetics. However, as only a limited number of patients were based implants in children and adolescents for fracture fixation,
treated with additional titanium wires, applications with very close osteotomy and osteochondral defect refixation. Patients who were
or direct contact must be avoided whenever possible, as rapid treated with those implants demonstrated adequate bone healing,
degradation with increased hydrogen gas formation should be an- did not experience prolonged wound healing and showed a low
ticipated [18], which may result in inferior osseous integration or rate of revision surgery, supporting the application of such im-
even the need for revision surgery. Implants showed stable fixa- plants. Furthermore, no general differences in outcomes were de-
tion, except in the single case of a highly unstable OD lesion [16]. tected among the skeletal sites.
However, long-term outcomes of the treatment of osteochondral
defects by magnesium-based implants are not yet available. Ethical approval
Whether to perform metal implant removal in children and
adolescents remains an ongoing debate in the literature, with no This study was approved by the institutional review board
consensus [23-25]. In line with our national guidelines [8], metal (Ethikkommission Ärztekammer Hamburg WF-075/20).
implant removal is performed to avoid potential complications,
such as pain, infection, growth disturbances, or mechanical dys- Authors’ contributions
function. Surgery itself poses risks for complications, and hospi-
talization affects quality of life [13,26]) and increases medical ex- JS conceived and designed the study, collected data and wrote
penses [23]. Therefore, the number of surgeries should be reduced, the manuscript. MMD collected data and reviewed the manuscript.
if possible, especially in children and adolescents. By implanting ODJ, RS, CK, TR reviewed the manuscript. MK and MR orga-
biodegradable magnesium-based screws, the need for a second nized and performed the study, enrolled patients and reviewed the
surgery is reduced by a relevant degree. manuscripts.
Radiolucent zones were apparent in all follow-up radiographs
but were of self-limiting character and did not affect the outcomes. Declaration of Competing Interests
As previously described in the literature [10,14,27], these zones are
a regular phenomenon and must not be misinterpreted during ra- MR advises the Syntellix AG (Hannover, Germany) on clinical
diographical evaluation. Reports in adults did not reveal the persis- matters. All other authors have no conflicts of interest to disclose.
tence of radiolucent zones at the three-year follow-up examination
[11].
Funding
There are limitations to this study, such as the retrospective
study design, the heterogeneous indication spectrum, the lack of
This study received no specific funding.
a control group and the use of X-rays instead of high-resolution
imaging. Regardless of these limitations, the size of our cohort and References
the large number of patients within the respective subgroups al-
lowed us to draw appropriate conclusions. [1] Rennie L, Court-Brown CM, Mok JY, Beattie TF. The epidemiology of fractures
However, this study reveals the paramount importance of trans- in children. Injury 2007;38(8):913–22.
[2] Mayranpaa MK, Makitie O, Kallio PE. Decreasing incidence and changing pat-
lational biomaterial science regarding corrosion kinetics in the
tern of childhood fractures: a population-based study. J Bone Miner Res
growing skeleton, as well as the host response. Although all ra- 2010;25(12):2752–9.
diolucent zones were diminished at later follow-up visits, fur- [3] Landin LA. Epidemiology of Children’s Fractures. J Pediatric Orthopaedics B
ther studies are needed, especially in the growing skeleton. If 1997;6(2).
[4] Mills LA, Simpson AH. The risk of non-union per fracture in children. J Child
magnesium-based implants demonstrate similar results as conven- Orthop 2013;7(4):317–22.
tional implants, their use in children and adolescents should be [5] Flynn JM, Luedtke LM, Ganley TJ, Dawson J, Davidson RS, Dormans JP,
strongly encouraged. et al. Comparison of titanium elastic nails with traction and a spica cast to
treat femoral fractures in children. J Bone Joint Surg Am 2004;86(4):770–7.
6
JID: JINJ
ARTICLE IN PRESS [m5G;March 25, 2021;20:15]
J. Stürznickel, M.M. Delsmann, O.D. Jungesblut et al. Injury xxx (xxxx) xxx
[6] Cheng JC, Ng BK, Ying SY, Lam PK. A 10-year study of the changes in the pat- [17] Witte F. The history of biodegradable magnesium implants: a review. Acta Bio-
tern and treatment of 6,493 fractures. J Pediatr Orthop 1999;19(3):344–50. mater 2010;6(5):1680–92.
[7] Rupp M, Schafer C, Heiss C, Alt V. Pinning of supracondylar fractures in chil- [18] Hou P, Han P, Zhao C, Wu H, Ni J, Zhang S, et al. Accelerating corrosion of pure
dren - Strategies to avoid complications. Injury 2019;50(Suppl 1):S2–9. magnesium Co-implanted with titanium in vivo. Sci Rep 2017;7(1):41924.
[8] Implantatentfernung nach Osteosynthese 2018 [Available from: https://www. [19] Yang Y, He C, Dianyu E, Yang W, Qi F, Xie D, et al. Mg bone implant: features,
awmf.org/uploads/tx_szleitlinien/012-004l_S1_Implantatentfernung-nach- developments and perspectives. Mater Des 2020;185:108259.
Osteosynthese_2018-08.pdf. [20] Witte F, Kaese V, Haferkamp H, Switzer E, Meyer-Lindenberg A, Wirth C,
[9] Windhagen H, Radtke K, Weizbauer A, Diekmann J, Noll Y, Kreimeyer U, et al. In vivo corrosion of four magnesium alloys and the associated bone re-
et al. Biodegradable magnesium-based screw clinically equivalent to titanium sponse. Biomaterials 2005;26(17):3557–63.
screw in hallux valgus surgery: short term results of the first prospective, ran- [21] Leonhardt H, Ziegler A, Lauer G, Franke A. Osteosynthesis of the mandibular
domized, controlled clinical pilot study. Biomed Eng Online 2013;12:62. condyle with magnesium-based biodegradable headless compression screws
[10] May H, Alper Kati Y, Gumussuyu G, Yunus Emre T, Unal M, Kose O. Bioab- show good clinical results during a 1-year follow-up period. J Oral Maxillofac
sorbable magnesium screw versus conventional titanium screw fixation for Surg 2020.
medial malleolar fractures. J Orthop Traumatol 2020;21(1):9. [22] Gigante A, Setaro N, Rotini M, Finzi SS, Marinelli M. Intercondylar eminence
[11] Plaass C, von Falck C, Ettinger S, Sonnow L, Calderone F, Weizbauer A, fracture treated by resorbable magnesium screws osteosynthesis: a case series.
et al. Bioabsorbable magnesium versus standard titanium compression screws Injury 2018;49(Suppl 3):S48–53.
for fixation of distal metatarsal osteotomies - 3 year results of a randomized [23] Gorter EA, Vos DI, Sier CF, Schipper IB. Implant removal associated complica-
clinical trial. J Orthop Sci 2018;23(2):321–7. tions in children with limb fractures due to trauma. Eur J Trauma Emerg Surg
[12] Noviana D, Paramitha D, Ulum MF, Hermawan H. The effect of hydrogen gas 2011;37(6):623–7.
evolution of magnesium implant on the postimplantation mortality of rats. J [24] Boulos A, DeFroda SF, Kleiner JE, Thomas N, Gil JA, Cruz AI Jr. Inpatient or-
Orthop Translat 2016;5:9–15. thopaedic hardware removal in children: a cross-sectional study. J Clin Orthop
[13] Rabbitts JA, Palermo TM, Zhou C, Mangione-Smith R. Pain and health-related Trauma 2017;8(3):270–5.
quality of life after pediatric inpatient surgery. J Pain 2015;16(12):1334–41. [25] Schmittenbecher PP. Implant removal in children. Eur J Trauma Emerg Surg
[14] Klauser H. Internal fixation of three-dimensional distal metatarsal I os- 2013;39(4):345–52.
teotomies in the treatment of hallux valgus deformities using biodegrad- [26] Winthrop AL, Brasel KJ, Stahovic L, Paulson J, Schneeberger B, Kuhn EM.
able magnesium screws in comparison to titanium screws. Foot Ankle Surg Quality of life and functional outcome after pediatric trauma. J Trauma
2019;25(3):398–405. 2005;58(3):468–73 discussion 73-4.
[15] Staiger MP, Pietak AM, Huadmai J, Dias G. Magnesium and its alloys as ortho- [27] Acar B, Kose O, Unal M, Turan A, Kati YA, Guler F. Comparison of magnesium
pedic biomaterials: a review. Biomaterials 2006;27(9):1728–34. versus titanium screw fixation for biplane chevron medial malleolar osteotomy
[16] Jungesblut OD, Moritz M, Spiro AS, Stuecker R, Rupprecht M. Fixation of in the treatment of osteochondral lesions of the talus. Eur J Orthop Surg Trau-
unstable osteochondritis dissecans lesions and displaced osteochondral frag- matol 2020;30(1):163–73.
ments using new biodegradable magnesium pins in adolescents. Cartilage
2020 1947603520942943.