Abstract
Background
Osseointegration has emerged over the past two decades as a dramatically different approach for the treatment of lower limb amputations, which involves direct attachment of the prosthesis to the skeletal residuum. This approach can address many of the socket–interface issues associated with socket prostheses which represent the current standard of care for amputees. The Osseointegrated Prosthetic Limb (OPL) is an osseointegration implant with a new design and improved features compared to other available implant systems.
Objectives
To report on the experience and outcomes of using the OPL for osseointegrated reconstruction of lower limb amputations.
Materials and methods
This is a retrospective study of 22 patients who received the OPL implant between December 2013 and November 2014. Clinical outcomes were obtained pre- and post-operatively, with results reported at the 1‑year follow-up. Outcome measures included the Questionnaire for persons with a Trans-Femoral Amputation (Q-TFA), Short Form Health Survey 36 (SF-36), Six-Minute Walk Test (6MWT), and Timed Up and Go (TUG). Adverse events were also recorded.
Results
Compared to the mean pre-operative values obtained while patients were using socket prostheses or were wheelchair-bound, the mean post-operative values for all four validated outcome measures were significantly improved. There were 15 episodes of minor infections in 12 patients, all of which responded to antibiotics. Soft tissue refashioning was performed electively on 6 patients. No other adverse events were recorded.
Conclusions
The results demonstrate that osseointegration surgery using the OPL is a relatively safe and effective procedure for the reconstruction and rehabilitation of lower limb amputees.
Zusammenfassung
Hintergrund
Die Osseointegration hat sich gegenüber der bisherigen Versorgung in den letzten beiden Jahrzehnten als völlig anderer Ansatz der Behandlung von Amputationen der unteren Extremitäten erwiesen, wozu die direkte Befestigung der Prothese an den verbliebenen Knochen gehört. Dieser Ansatz kann viele der Probleme zwischen Stumpf und Schaft lösen, die mit den Schaftprothesen verbunden sind, welche derzeit den Versorgungsstandard für Patienten nach Amputation darstellen. Das Osseointegrated Prosthetic Limb (OPL) ist eine Osseointegrationsimplantat mit neuem Design und verbesserten Eigenschaften im Vergleich zu den anderen verfügbaren Implantationssystemen.
Ziel der Arbeit
Ziel war, über Erfahrungen und Ergebnisse beim Einsatz des OPL zur osseointegrierten Rekonstruktion von Beinamputationen zu berichten.
Material und Methoden
Es handelt sich um eine retrospektive Studie an 22 Patienten, die zwischen Dezember 2013 und November 2014 ein OPL-Implantat erhielten. Klinische Parameter wurden prä- und postoperativ erhoben sowie die Ergebnisse nach einjähriger Nachbeobachtung erfasst. Ergebnisparameter waren ein Fragebogen für Beinamputierte (Questionnaire for persons with a Trans-Femoral Amputation, Q‑TFA), der Short Form Health Survey 36 (SF-36), der 6‑min-Gehtest (Six-Minute Walk Test, 6MWT) und die Messung der Zeit für Aufstehen und Gehen (Timed Up and Go, TUG). Unerwünschte Ereignisse wurden ebenfalls dokumentiert.
Ergebnisse
Im Vergleich zu den mittleren präoperativen Werten, während die Patienten Schaftprothesen trugen oder an den Rollstuhl gebunden waren, verbesserten sich die mittleren postoperativen Werte für alle 4 validierten Ergebnisparameter signifikant. Es gab 15 Episoden leichterer Infektionen bei 12 Patienten, die alle auf Antibiotika ansprachen. Ein Korrektureingriff an den Weichteilen erfolgte elektiv bei 6 Patienten. Es wurden keine weiteren unerwünschten Ereignisse dokumentiert.
Schlussfolgerung
Die Ergebnisse zeigen, dass die Osseointegrationschirurgie mit Verwendung des OPL ein relativ sicheres und wirksames Verfahren zur Rekonstruktion und Rehabilitation von Patienten nach Beinamputation darstellt.
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M. Al Muderis reports royalties for design contributions from Permedica S.p.A (Milan, Italy) and AQ Implants GmbH (Ahrensburg, Germany) during the conduct of the study. W. Lu and J.J. Li report personal fees from Osseointegration International Pty Ltd (Sydney, Australia) during the conduct of the study.
This article does not contain any studies with animals, but involve human paticipants for which institutional approval has been obtained from the human research ethics committee, and all participants gave their informed consent (Sydney: 014153S).
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H. Aschoff, Lübeck
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Al Muderis, M., Lu, W. & Li, J. Osseointegrated Prosthetic Limb for the treatment of lower limb amputations. Unfallchirurg 120, 306–311 (2017). https://doi.org/10.1007/s00113-016-0296-8
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DOI: https://doi.org/10.1007/s00113-016-0296-8