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

Abstract

Introduction: Lower limb amputations have detrimental influences on the quality of life, function and body image of the affected patients. Following amputation, prolonged rehabilitation is required for patients to be fitted with traditional socket prostheses, and many patients experience symptomatic socket-residuum interface problems which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged 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 2 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 ∼3-6 weeks.

Methods and analysis: The inclusion criteria for osseointegrated reconstruction under the OGAAP-2 procedure are age over 18 years, unilateral transfemoral amputation and experiencing problems or difficulties in using socket prostheses. All patients receive osseointegrated implants which are press-fitted into the residual bone. Functional and quality-of-life outcome measures are recorded preoperatively and at defined postoperative follow-up intervals up to 2 years. Postoperative adverse events are also recorded. The preoperative and postoperative values are compared for each outcome measure, and the benefits and harms of the single-stage OGAAP-2 procedure will be compared with the results obtained using a previously employed 2-stage procedure.

Ethics and dissemination: This study has received ethics approval from the University of Notre Dame, Sydney, Australia (014153S). The study outcomes will be disseminated by publications in peer-reviewed academic journals and presentations at relevant clinical and orthopaedic conferences.

Keywords: Lower limb amputees; Osseointegration; Single-stage surgery.

Figure 1

Overview of the single-stage Osseointegration Group of Australia Accelerated Protocol-2 clinical programme and outcomes evaluation for the osseointegrated reconstruction of lower limb amputations.

Figure 2

The Osseointegrated Prosthetic Limb implant system (Permedica s.p.a; Milan, Italy) used for the osseointegrated reconstruction of trans-femoral amputations under the Osseointegration Group of Australia Accelerated Protocol-2 procedure. The implant consists of an intramedullary stem component and a dual-cone adaptor component.

Figure 3

Steps involved in single-stage osseointegration surgery under the Osseointegration Group of Australia Accelerated Protocol-2. (A) Identification and terminalisation of neuromas during soft tissue preparation. (B) Completed guillotine amputation of the stump. (C) Reaming of the medullary canal and preparation of the distal femur to accommodate the flange of the intramedullary stem component of the osseointegration implant. (D) Insertion of the intramedullary stem by impacting with a mallet. (E) Creation of the stoma site and insertion of the dual-cone adaptor component of the osseointegration implant. (F) Stoma site postoperation, showing the inserted dual-cone adaptor and remaining parts of the abutment.