Single-Stage Osseointegrated Reconstruction and Rehabilitation of Lower Limb Amputees: The Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2) for a Prospective Cohort Study

Osseointegration has emerged over the last two decades as a novel approach for the reconstruction of amputated limbs, which overcomes many of the socket-related problems by directly attaching the prosthesis to the skeletal residuum. To date, the vast majority of osseointegration procedures worldwide have been performed in two stages, which require at least 4 months and up to 18 months for the completion of reconstruction and rehabilitation from the time of the initial surgery. The current prospective cohort study evaluates the safety and efficacy of a single-stage osseointegration procedure performed under the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2), which dramatically reduces the time of recovery to approximately 3–6 weeks without compromising the outcomes.

Functional (Six Minute Walk Test, Timed Up and Go, and K-Levels) and quality of life (Questionnaire for persons with a Trans-Femoral Amputation, and Short Form Health Survey 36) outcome measures are recorded pre-operatively and at defined post-operative follow-up intervals up to 2 years. Post-operative adverse events (infection, revision surgery, fractures, and implant failures) are also recorded. The pre- and post-operative values are compared for each outcome measure, and the benefits and harms of the single-stage OGAAP-2 procedure will be compared to the results obtained using a previously employed two-stage procedure.