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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
  1. Munjed Al Muderis1,2,3,
  2. William Lu4,
  3. Kevin Tetsworth5,6,
  4. Belinda Bosley3,
  5. Jiao Jiao Li4
  1. 1The Australian School of Advanced Medicine, Macquarie University, North Ryde, New South Wales, Australia
  2. 2School of Medicine, University of Notre Dame, Auburn, New South Wales, Australia
  3. 3Norwest Private Hospital, Bella Vista, New South Wales, Australia
  4. 4Biomaterials and Tissue Engineering Research Unit, School of AMME, University of Sydney, Sydney, New South Wales, Australia
  5. 5Royal Brisbane Hospital, Herston, Queensland, Australia
  6. 6School of Medicine, University of Queensland, Brisbane, Queensland, Australia
  1. Correspondence to Dr Jiao Jiao Li; jiaojiao.li{at}sydney.edu.au

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.

  • Osseointegration
  • Lower limb amputees
  • Single-stage surgery

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors MAM is responsible for study design, patient care and surgical procedure, and manuscript preparation. WL is responsible for data collection and manuscript revision. KT is responsible for study design, statistical planning and manuscript revision. BB is responsible for patient care, data collection and manuscript revision. JJL is responsible for data collection and manuscript preparation and revision.

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests MAM receives royalties for design contributions for the Osseointegrated Prosthetic Limb (OPL; Permedica s.p.a; Milan, Italy) implant system.

  • Ethics approval University of Notre Dame, Sydney, Australia.

  • Provenance and peer review Not commissioned; externally peer reviewed.