• Prosthet Orthot Int · Feb 2019

    Clinical Trial

    UK trial of the Osseointegrated Prosthesis for the Rehabilitation for Amputees: 1995-2018.

    • Douglas John Matthews, Mateen Arastu, Maggie Uden, John Paul Sullivan, Kristina Bolsakova, Kingsley Robinson, Sellaiah Sooriakumaran, and David Ward.
    • 1 Kingston Hospital NHS Foundation Trust, Kingston upon Thames, UK.
    • Prosthet Orthot Int. 2019 Feb 1; 43 (1): 112-122.

    Background:Amputation of a limb impacts on patients' self-perception and quality of life. Prostheses directly anchored to the skeleton are being investigated, aiming to avoid soft tissue complications.Objectives:We report outcome data for the UK trial of the Osseointegrated Prosthesis for the Rehabilitation of Amputees Implant System with a minimum of 9-year follow-up.Methods:Eighteen transfemoral amputees received unilateral implants between 1997 and 2008. Five were implanted before a formalised protocol, called Osseointegrated Prosthesis for the Rehabilitation of Amputees, was developed. Mean follow-up of the Pre-Osseointegrated Prosthesis for the Rehabilitation of Amputees group is 11.4 years (1.8-18.6 years), while for the Post-Osseointegrated Prosthesis for the Rehabilitation of Amputees group it is 12.3 years (2.9-15.9).Results:The Kaplan-Meier cumulative survivorship is 40% for the Pre-Osseointegrated Prosthesis for the Rehabilitation of Amputees group and 80.21% for the Post-Osseointegrated Prosthesis for the Rehabilitation of Amputees group. Five implants (28%) have been removed, three (17%) for deep infection, one (5.6%) for chronic pain, later proven to be infected and one (5.6%) due to implant fracture secondary to loosening due to infection. Two patients (11%) have peri-implant infections suppressed with oral antibiotics. Eleven cases (61%) of superficial infection were successfully treated with antibiotics. 36-Item short-form health survey and Questionnaire for persons with a Transfemoral Amputation showed significant improvements in quality of life up to 5 years after implantation.Conclusion:This small cohort of patients demonstrates osseointegrated prosthesis allows prolonged usage and improves patients' quality of life compared to conventional prostheses.Clinical RelevanceThese prostheses may provide a future gold standard for amputees and this study provides the first outcome data over such a time period to be reported from outside of the developers group.

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