A five-year follow-up study reported on safety, prosthesis-wearing time, and health-related quality-of-life (HRQoL) for patients with femoral bone-anchored prostheses, and found that despite some adverse events, patient prosthetic use and HRQoL improved significantly. The results were published in The Journal of Bone and Joint Surgery.
Thirty-nine of 42 eligible patients who underwent press-fit osseointegration implantation at Radboud University Medical Center, the Netherlands, between May 2009 and November 2013 were included in the study. 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 patients (77 percent) presented with some kind of infection (156 events in total), with 148 events (95 percent) classified as grade 1 or 2 and eight events (5 percent) classified as grade 3; the latter eight events occurred in four patients. There were no instances of septic loosening. The intramedullary stem of the osseointegration implant broke in two patients. 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.
While grade 1 and 2 infections were frequent, they could mostly be treated with nonoperative measures. Most infections seemed to occur in the first two years and did not lead to deep infections, and two broken intramedullary stems were successfully revised.