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

IntroductionLower 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 analysisThe 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 disseminationThis 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.

Percutaneous Osseointegrated Prostheses for Transfemoral Amputations

“…Single-stage surgeries can be performed in selected patients with optimal bone quality and good compliance. This is in accordance with the experience of Al Muderis et al 21 with ILP devices. The authors agree that a singlestage surgical protocol reduces perioperative risks as well as bleeding, pain, hospital stay, and likely the rehabilitation period.…”

Analysis of the Stomal Microbiota of a Percutaneous Osseointegrated Prosthesis: A Longitudinal Prospective Cohort Study

“…Although most percutaneous OI devices used today differ in implant design, device materials, surface methods of osseointegration, means of skin attachment, surgical implantation techniques, time to full ambulation, modes of mechanical failure, aseptic loosening, and stress shielded bone resorption, these systems share a single commonality in that they all require an opening in the skin, referred to as “the stoma,” through which an artificial limb is connected to the appendicular skeleton . Clinical reports indicate that most of these percutaneous devices become infected one or more times during their lifetime and that these infections are usually superficial and readily treated with appropriate oral antibiotics …”

Biomechanical Characterisation of Bone-anchored Implant Systems for Amputation Limb Prostheses: A Systematic Review

“…The other systems have mostly followed two-stage surgical protocols, although single-stage procedures have been reported for the OPRA, the OPL and the COMPRESS systems. 7 , 56 , 57 In the first stage, an incision is made in the distal end of the stump, the residual bone is reamed and prepared for insertion of the implant, and the implant is then inserted and the skin is closed. The bone and the skin are allowed to heal for a period of time to enable osseointegration between the bone and the implant.…”