Safety and Performance of Bone-Anchored Prostheses in Persons with a Transfemoral Amputation: A 5-Year Follow-up Study.

Abstract

For almost 30 years, bone-anchored prostheses have offered an alternative solution to prosthetic sockets by attaching the artificial limb directly to the femoral residuum by means of an osseointegration implant. Osseointegration implant surgery was introduced in our center in 2009. The aim of the present study is to report on safety, prosthesis-wearing time, and health-related quality-of-life (HRQoL) for patients with femoral bone-anchored prostheses during a 5-year follow-up period. All patients who underwent implantation of a press-fit osseointegration implant between May 2009 and November 2013 were eligible for the present study. Implantation was performed in 2 stages. Adverse events included infectious complications (grade 1 to 4), aseptic loosening, breakage, stoma-redundant tissue, and stoma hypergranulation. Prosthesis-wearing time and HRQoL were measured with the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) prosthetic use score and global score, respectively. Thirty-nine of 42 eligible patients were included. Thirty patients (77%) presented with some kind of infection (156 events in total), with 148 (95%) events being classified as grade 1 or 2 and 8 events (5%) being classified as grade 3; the latter 8 events occurred in 4 patients. There were no instances of septic loosening. The intramedullary stem of the osseointegration implant broke in 2 patients. In total, soft-tissue refashioning had to be done 30 times in 14 patients. The Q-TFA median prosthetic use and global scores improved significantly from 71 to 100 and from 33 to 75, respectively (p < 0.001). Despite the adverse events, patient prosthetic use and HRQoL improved significantly. Grade-1 and 2 infections were frequent but could mostly be treated with nonoperative measures. Most infections seemed to occur in the first 2 years and did not lead to deep infections. Two broken intramedullary stems were revised successfully. Current developments focus on reduction of infectious complications and prevention of osseointegration implant breakage. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.