Single-stage transcutaneous osseointegrated prosthesis for above-knee amputations including an antibiotic-loaded hydrogel. Preliminary results of a new surgical protocol.

Abstract

Patients with above-knee amputations (AKA) are normally treated with the traditional socket-mounted prosthesis (SMP), which is associated with a high incidence of problems. Osseointegration has been proposed as a promising option for avoiding many common SMP drawbacks. Several concerns have arisen regarding amputee osseointegration, however, mainly with respect to infection. We report on the safety of a single-stage osseointegration protocol using an antibiotic-loaded hydrogel to coat the intramedullary implant. We retrospectively reviewed all AKA cases treated at our center between January 2019 and April 2022, in which a transcutaneous osseointegrated implant was used in a single-stage strategy, together with a rapid-resorbable hydrogel loaded with vancomycin and gentamicin. The specific protocol used, infection rate, implant osseointegration rate and implant survivorship were determined after a minimum follow-up of 12 months. Eleven osseointegration cases were included in the study, with an average of 16 years post-amputation (range: 3-35 years). After a median follow-up of 24 months (range 12-49 months) no patient had suffered any implant-related infection. Osseointegration of the implant had been achieved in all cases. The mid-term survivorship of the implant in our series was 100 % at the end of follow-up. Radiographs of all cases showed no loosening of the implant. Further, 91 % of the series patients were able to walk without restrictions after the rehabilitation process. The single-stage osseointegration protocol for AKA, using a rapid-resorbable hydrogel loaded with vancomycin and gentamicin, yields low rates of implant-related deep infection. This protocol consistently delivers high rates of radiological osseointegration, with no hydrogel-associated complications.