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

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. 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. 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). 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. This small cohort of patients demonstrates osseointegrated prosthesis allows prolonged usage and improves patients’ quality of life compared to conventional prostheses. These 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