In vitro and in silico methods for the biomechanical assessment of osseointegrated transfemoral prostheses: a systematic review
Abstract
The amputee population according to the World-Health-Organization is about 40 million. However, there is a high abandon rate of socket prostheses for the lower limb (25%–57%). The direct connection between the external prosthesis and the patient’s bone makes osseointegrated prostheses for transfemoral amputees advantageous (e.g., improvement of the motor control) compared to socket prostheses, which are currently the gold standard. However, similarly to other uncemented prostheses, the osseointegrated ones are at risk of aseptic loosening and adverse bone remodelling caused by stress-shielding. The preclinical assessment of these prostheses has already been evaluated using different methods which did not provide unanimous and comparable evidence. To compare data from different investigations, a clear and detailed overview of the methods used to assess the performance is necessary. In this review 17 studies investigating the primary stability, stress shielding and stress concentration of osseointegrated transfemoral prostheses are examined. Primary stability consists in the biomechanical stability upon implant insertion. Primary stability is assessed measuring extraction force (either with a pull-out or a push-out test) and micromotion at the interface between the implant and the host bone with LVDT (in vitro test) or numerical models. Stress-shielding causes adaptive changes in the bone density around metal implants, and thus in the bone strength and stiffness.…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in cell cultures (in vitro) and computer models (in silico), not in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
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