Early Experience with Femoral and Tibial Bone-Anchored Osseointegration Prostheses.

BACKGROUND

The use of bone-anchored osseointegration implants for amputation reconstruction continues to expand throughout the world. Benefits are thought to include the elimination of socket-related problems and improved control and proprioception of the prosthetic limb. Reported outcomes have been positive, but skepticism remains with regard to the risk of infection and implant failure. Further results from early adopters are therefore needed prior to widespread acceptance and regulatory approval.

METHODS

A retrospective review of the first 31 consecutive patients who underwent implantation of a press-fit osseointegration implant of the femur or tibia with follow-up of at least 6 months was performed. The primary outcome was the patient-reported Questionnaire for persons with a Transfemoral Amputation (Q-TFA) measured preoperatively and 6 to 12 months postoperatively. Patient-Reported Outcomes Measurement Information System (PROMIS) and Limb Deformity-Scoliosis Research Society (LD-SRS) scores, 2-minute and 6-minute walk tests, and complications were also recorded.

RESULTS

In this study, 18 femoral reconstructions and 13 tibial reconstructions were performed, with a mean follow-up (and standard deviation) of 21.1 ± 9.2 months. Twenty-eight reconstructions were single-stage implantations. All Q-TFA domains improved significantly (p < 0.001) from preoperatively to postoperatively, including the global score (25.0 ± 17.4 to 81.2 ± 17.6 points), prosthetic use (50.2 ± 39.9 to 91.2 ± 18.7 points), prosthetic mobility (49.7 ± 26.9 to 81.4 ± 21.5 points), and prosthetic problems (46.4 ± 17.5 to 9.1 ± 6.6 points). The overall and functional outcome domains of the PROMIS and LD-SRS and the 2-minute walk test (243 ± 107 to 369 ± 151 ft [74 ± 33 to 112 ± 46 m]; p = 0.022) and 6-minute walk test (609 ± 323 to 1,054 ± 555 ft [186 ± 98 to 321 ± 169 m]; p = 0.016) also improved significantly. Serious adverse events included 2 periprosthetic hip fractures, 1 explantation for septic loosening, and 1 explantation for aseptic loosening, with an overall implant retention of 93%. The most common complication was low-grade, soft-tissue infection requiring oral antibiotics.

CONCLUSIONS

Similar to the early experience of other international centers, osseointegration implants improved the overall and functional experience of patients compared with socket prosthetics. Complications were present but manageable and were not a deterrent to ongoing support of the technology.

LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.