Abstract
Purpose
To evaluate the implant survival rate, mechanical complications, and reported patient outcomes of bone-anchored prostheses for patients with lower limb amputation in France after 1–15 years of follow-up.
Methods
This retrospective cohort study included patients who underwent surgery at a single center in France between 2007 and 2021. The primary outcomes were the implant survival rate and functional scores assessed by the Questionnaire for Transfemoral Amputees (Q-TFA). Secondary outcomes were adverse events that occurred during follow-up.
Results
The cohort consisted of 20 bone-anchored prostheses in 17 patients. The main level of amputation was transfemoral (82%, n = 14). The main reason for amputation was trauma (n = 15). The mean age at amputation was 32 (range 15–54) years, and the mean age at the first stage of osseointegration was 41 (range 21–58) years. The Kaplan–Meier survival curve showed respective survival rates of 90%, 70%, and 60% at 2, 10, and 15 years. All Q-TFA scores were significantly improved at last the follow-up. Eleven patients (65%) experienced mechanical complications. In total, 37 infectious events occurred in 13 patients (76%), mainly comprising stage 1 infections (68%, n = 25). Only two cases of septic loosening occurred (12%), leading to implant removal.
Conclusion
This is the first French cohort of bone-anchored prostheses and among the series with the longest follow-up periods. The findings indicate that bone-anchored prostheses are safe and reliable for amputee patients who have difficulties with classic prostheses.
Similar content being viewed by others
Data availability
All data relevant to the study are included in the article or are available as supplementary files.
Code availability
Not applicable.
References
Haute Autorité de Santé (2021) Avis de la CNEDiMTS, Dynastep 1A101, pied à restitution d’énergie de classe I, HAS
Haute Autorité de Santé (2010) Evaluation des prothèses externes de membre supérieur, HAS
Haute Autorité de Santé (2021) Avis de la CNEDiMTS, Système Myobock, prothèse externe myoélectrique pour membre supérieur, HAS
Ziegler-Graham K, MacKenzie EJ, Ephraim PL et al (2008) Estimating the prevalence of limb loss in the United States: 2005–2050. Arch Phys Med Rehabil 89:422–429. https://doi.org/10.1016/j.apmr.2007.11.005
Dillingham TR, Pezzin LE, MacKenzie EJ (2002) Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J 95:875–883. https://doi.org/10.1097/00007611-200208000-00018
Low EE, Inkellis E, Morshed S (2017) Complications and revision amputation following trauma-related lower limb loss. Injury 48:364–370. https://doi.org/10.1016/j.injury.2016.11.019
Dillingham TR, Pezzin LE, MacKenzie EJ, Burgess AR (2001) Use and satisfaction with prosthetic devices among persons with trauma-related amputations: a long-term outcome study. Am J Phys Med Rehabil 80:563–571. https://doi.org/10.1097/00002060-200108000-00003
Brånemark R, Brånemark PI, Rydevik B, Myers RR (2001) Osseointegration in skeletal reconstruction and rehabilitation. J Rehabil Res Dev 38:1–4
Hagberg K, Häggström E, Uden M, Brånemark R (2005) Socket versus bone-anchored trans-femoral prostheses: hip range of motion and sitting comfort. Prosthet Orthot Int 29:153–163. https://doi.org/10.1080/03093640500238014
Örgel M, Elareibi M, Graulich T et al (2021) Osseoperception in transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation: a prospective study. Arch Orthop Trauma Surg. https://doi.org/10.1007/s00402-021-04099-1
Atallah R, van de Meent H, Verhamme L et al (2020) Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: a prospective one-year follow-up cohort study. PLoS ONE 15:e0230027. https://doi.org/10.1371/journal.pone.0230027
Hagberg K, GhassemiJahani S-A, Kulbacka-Ortiz K et al (2020) A 15-year follow-up of transfemoral amputees with bone-anchored transcutaneous prostheses: mechanical complications and patient-reported outcomes. Bone Jt J 102:55–63. https://doi.org/10.1302/0301-620X.102B1.BJJ-2019-0611.R1
Matthews DJ, Arastu M, Uden M et al (2019) UK trial of the osseointegrated prosthesis for the rehabilitation for amputees: 1995–2018. Prosthet Orthot Int 43:112–122. https://doi.org/10.1177/0309364618791616
Reetz D, Atallah R, Mohamed J et al (2020) Safety and performance of bone-anchored prostheses in persons with a transfemoral amputation: a 5-year follow-up study. J Bone Jt Surg Am 102:1329–1335. https://doi.org/10.2106/JBJS.19.01169
Reif TJ, Khabyeh-Hasbani N, Jaime KM et al (2021) Early experience with femoral and tibial bone-anchored osseointegration prostheses. JB JS Open Access 6(e21):00072. https://doi.org/10.2106/JBJS.OA.21.00072
Zaid MB, O’Donnell RJ, Potter BK, Forsberg JA (2019) Orthopaedic osseointegration: state of the art. J Am Acad Orthop Surg 27:E977–E985. https://doi.org/10.5435/JAAOS-D-19-00016
Bertrand M, Brannemark R (2014) Ostéointégration pour la réhabilitation des amputés. Ann Phys Rehabil Med 57:e131. https://doi.org/10.1016/j.rehab.2014.03.468
Brånemark R (2011) OPRA Implant system, instructions for use, integrum
Hagberg K, Brånemark R (2009) One hundred patients treated with osseointegrated transfemoral amputation prostheses–rehabilitation perspective. J Rehabil Res Dev 46:331–344
Hagberg K, Brånemark R, Hägg O (2004) Questionnaire for persons with a transfemoral amputation (Q-TFA): initial validity and reliability of a new outcome measure. J Rehabil Res Dev 41:695–706
Al Muderis M, Khemka A, Lord SJ et al (2016) Safety of osseointegrated implants for transfemoral amputees: a two-center prospective cohort study. J Bone Joint Surg Am 98:900–909. https://doi.org/10.2106/JBJS.15.00808
Örgel M, Schwarze F, Graulich T et al (2022) Comparison of functional outcome and patient satisfaction between patients with socket prosthesis and patients treated with transcutaneous osseointegrated prosthetic systems (TOPS) after transfemoral amputation. Eur J Trauma Emerg Surg. https://doi.org/10.1007/s00068-022-02018-6
Pospiech PT, Wendlandt R, Aschoff H-H et al (2020) Quality of life of persons with transfemoral amputation: comparison of socket prostheses and osseointegrated prostheses. Prosthet Orthot Int. https://doi.org/10.1177/0309364620948649
Branemark R, Berlin O, Hagberg K et al (2014) A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: a prospective study of 51 patients. Bone Jt J 96B:562
Atallah R, Leijendekkers RA, Hoogeboom TJ, Frölke JP (2018) Complications of bone-anchored prostheses for individuals with an extremity amputation: a systematic review. PLoS ONE 13:e0201821. https://doi.org/10.1371/journal.pone.0201821
Hebert JS, Rehani M, Stiegelmar R (2017) Osseointegration for lower-limb amputation: a systematic review of clinical outcomes. JBJS Rev 5:e10. https://doi.org/10.2106/JBJS.RVW.17.00037
Juhnke D-L, Beck JP, Jeyapalina S, Aschoff HH (2015) Fifteen years of experience with integral-leg-prosthesis: cohort study of artificial limb attachment system. J Rehabil Res Dev 52:407–420. https://doi.org/10.1682/JRRD.2014.11.0280
Aschoff HH, Kennon RE, Keggi JM, Rubin LE (2010) Transcutaneous, distal femoral, intramedullary attachment for above-the-knee prostheses: an endo-exo device. J Bone Jt Surg 92:180–186. https://doi.org/10.2106/JBJS.J.00806
Van de Meent H, Hopman MT, Frölke JP (2013) Walking ability and quality of life in subjects with transfemoral amputation: a comparison of osseointegration with socket prostheses. Arch Phys Med Rehabil 94:2174–2178. https://doi.org/10.1016/j.apmr.2013.05.020
Leijendekkers RA, van Hinte G, Frölke JP et al (2019) Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study. Clin Rehabil 33:450–464. https://doi.org/10.1177/0269215518815215
Brånemark RP, Hagberg K, Kulbacka-Ortiz K et al (2019) Osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: a prospective five-year follow-up of patient-reported outcomes and complications. J Am Acad Orthop Surg 27:e743–e751. https://doi.org/10.5435/JAAOS-D-17-00621
Lundberg M, Hagberg K, Bullington J (2011) My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb. Prosthet Orthot Int 35:207–214. https://doi.org/10.1177/0309364611409795
Akhtar MA, Hoellwarth JS, Tetsworth K et al (2022) Osseointegration following transfemoral amputation after infected total knee replacement: a case series of 10 patients with a mean follow-up of 5 years. Arthroplast Today 16:21–30. https://doi.org/10.1016/j.artd.2022.04.008
Al Muderis M, Lu W, Li JJ (2017) Osseointegrated prosthetic limb for the treatment of lower limb amputations: experience and outcomes. Unfallchirurg 120:306–311. https://doi.org/10.1007/s00113-016-0296-8
Hagberg K, Brånemark R, Gunterberg B, Rydevik B (2008) Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up. Prosthet Orthot Int 32:29–41. https://doi.org/10.1080/03093640701553922
McMenemy L, Ramasamy A, Sherman K et al (2020) Direct Skeletal Fixation in bilateral above knee amputees following blast: 2 year follow up results from the initial cohort of UK service personnel. Injury 51:735–743. https://doi.org/10.1016/j.injury.2020.01.006
Tsikandylakis G, Berlin Ö, Brånemark R (2014) Implant survival, adverse events, and bone remodeling of osseointegrated percutaneous implants for transhumeral amputees. Clin Orthop Relat Res 472:2947–2956. https://doi.org/10.1007/s11999-014-3695-6
Acknowledgements
Not applicable.
Funding
There is no funding source.
Author information
Authors and Affiliations
Contributions
All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by CT, MBM and AD. The first draft of the manuscript was written by CT and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Thouvenin, C., Bertrand-Marchand, M., Klotz, R. et al. Bone-anchored prostheses for lower limb amputation in a French cohort with 1–15 years of follow-up: implant survival rates, mechanical complications, and reported outcomes. Eur J Orthop Surg Traumatol 34, 885–892 (2024). https://doi.org/10.1007/s00590-023-03738-0
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00590-023-03738-0