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Evaluation framework to assess clinical outcomes of bone-anchored prostheses: the truth and nothing but the truth!
Conference poster   Open access

Evaluation framework to assess clinical outcomes of bone-anchored prostheses: the truth and nothing but the truth!

Laurent Frossard
International Conference on Medical Bionics: Convergence science delivering clinical solutions, 4th (Brisbane, Australia, 20-Nov-2016–23-Nov-2016)
Bionics Institute
2016
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Abstract

Human Movement and Sports Science Biomedical Engineering osseointegration bone-anchored prosthesis evaluation framework amputation clinical outcome
Bone-anchored prostheses (BAP) are increasingly acknowledged as a viable alternative method of attachment of artificial limb compared to socket-suspended prostheses. Clearly, the current momentum for BAP experienced worldwide is creating a need for a guideline to evaluate the true clinical outcomes of these procedures. The aim of this study is to share the key elements of an evaluation framework recently developed in Australia to determine the benefits and harms of BAP. Methods: The proposed evaluation framework to determine the true clinical outcomes BAP for individuals with amputation was built upon scoping review including seminal studies focusing on clinical benefits and safety of procedures. Results: A standard and replicable evaluation framework should focus on at least, but not limited to: • The clinical benefits with a systematic recording of health-related quality of life, mobility predictor, ambulation abilities, walking abilities and actual activity level at baseline and follow-up post-surgery. • The potential harms with systematic recording of residuum care, infection, implant stability, implant integrity, injuries after Stage 1 surgery and up to two years follow-up. Conclusion: There was a general consensus around the instruments to monitor most of the benefits and harms. The benefits could be assessed using a wide spectrum of complementary assessments ranging from subjective patient self-reporting to objective measurements of physical activity. However, this latter was assessed using a broad range of measurements (e.g., pedometer, load cell, energy consumption). More importantly, the lack of consistent grading of infections was sufficiently noticeable to impede cross-fixation comparisons. Clearly, a more standardized grading system is needed. Scientists, clinicians and policy makers investigating the true clinical outcomes of BAP are encouraged to implement an framework featuring the domains and instruments suggested above using a single database to facilitate reflective practice and, eventually, robust prospective studies.

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