Though osseointegrated implants (OI) for patients with transfemoral amputations are a novel treatment under development, prospective long-term evidence is lacking. Researchers conducted a study to determine patient-reported outcomes (PROs) and complications after ten years compared to before treatment and to compare the first five-year period with the later five-year period with regard to the outcomes.
In a nonrandomized, prospective cohort study, 51 patients (28 men and 23 women) with transfemoral amputations treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system were followed for ten years in a single university hospital. The patients’ mean age at amputation was 32 years old; mean age at treatment was 44 years old.
PROs included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA, four scores 0-100) and the Short Form 36 Health Survey (SF-36, ten scores 0-100) and were answered before treatment and until the ten-year follow-up after treatment.
According to the researchers, PROs showed statistically significant mean improvements between baseline and the ten-year follow-up with regard to all Q-TFA scores: the prosthetic use score (+36), prosthetic mobility score (+18), problem score (-28) and global score (+38), and the SF-36 physical functioning score (+26) and physical component score (+6). No PROs showed a statistically significant deterioration.
Over the ten years, 12 patients were lost: one lost to follow-up, one dropped out of the study, two died, and eight had implants removed (four before five years and four between five and ten years). At ten years, the revision-free survival rates were 83 percent, 65 percent, and 17 percent for implant revision, deep infection, and mechanical complications, respectively.
Mechanical complications, 3.9 per ten person-years, constituted the most common serious adverse event and were more common during the last five years than during the first five years. No significant difference in the incidence of deep infections was observed between the earlier and the later five-year periods. Correlation analyses between the earlier and later five years revealed a positive association between deep infections and implant removal and between mechanical complications and adverse events.
The researchers concluded that though improved PROs were demonstrated ten years after the introduction of a novel principle for bone anchorage of amputation prostheses, an increasing rate of mechanical complications remains a concern.
The open-access study, “Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications,” was published in the Journal of Orthopaedic Translation.
