A team of researchers analyzed patient-reported outcomes and complications of transfemoral osseointegration (OI) after ten years. They found that the participants, who were treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system, reported improved physical health-related quality of life (HRQoL), more hours of prosthesis use, better mobility, fewer problems, and an improved situation overall compared to their situation before treatment.
The findings also included lowered implant survival, increased numbers of mechanical complications of the percutaneous modular parts, and associations between mechanical complications and prosthetic mobility and other complications including deep infection, which suggest that the implant system and treatment still require improvements, further research, and follow-up periods beyond ten years, according to the study.
In the nonrandomized, prospective cohort study, 51 patients with transfemoral amputations treated with the OPRA system in a single university hospital were followed for ten years. The cohort included 28 men and 23 women with a mean age at amputation of 32 years old. Their mean age at treatment was 44 years old.
Patient-reported outcomes included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) and the Short Form 36 Health Survey (SF-36) that were answered before treatment and until the ten-year follow-up after treatment.
The outcomes showed statistically significant mean improvements between the baseline and ten-year follow-up with regard to all Q-TFA scores. None of the outcomes showed a statistically significant deterioration. Over the ten years, 12 patients were lost. At ten years, the revision-free survival rates were 83 percent for implant revision, 65 percent for deep infection, and 17 percent for and mechanical complications.
Mechanical complications, 3.9 per 10 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.
While improvements in patient-reported outcomes were demonstrated ten years OI, the increasing rate of mechanical complications is of concern, the study’s authors concluded.
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.