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

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 Relevance: 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.