Osseointegration for Lower Limb Amputation: Understanding the Risk Factors and Time Courses of Soft Tissue Complications.

Abstract

Lower-limb osseointegrated prostheses are a novel alternative to traditional socket-suspended prostheses, which are often associated with poor fit, soft tissue damage, and pain. Osseointegration eliminates the socket-skin interface and allows for weight-bearing directly on the skeletal system. However, these prostheses can also be complicated by postoperative issues that can negatively impact mobility and quality of life. Little is known about the incidence of or risk factors for these complications as few centers currently perform the procedure. A retrospective analysis was performed on all patients who underwent single-stage lower limb osseointegration at our institution between 2017 and 2021. Patient demographics, medical history, operative data, and outcomes were collected. Fisher exact test and unpaired t tests were performed to identify risk factors for each adverse outcome, and time-to-event survival curves were generated. Sixty patients met our study criteria: 42 males and 18 females with 35 transfemoral and 25 transtibial amputations. The cohort had an average age of 48 years (range, 25-70 years) and follow-up period of 22 months (range, 6-47 months). Indications for amputation were trauma (50), prior surgical complication (5), cancer (4), and infection (1). Postoperatively, 25 patients developed soft tissue infections, 5 developed osteomyelitis, 6 had symptomatic neuromas, and 7 required soft tissue revisions. Soft tissue infections were positively correlated with obesity and female sex. Neuroma development was associated with increased age at osseointegration. Neuromas and osteomyelitis were both associated with decreased center experience. Subgroup analysis by amputation etiology and anatomic location did not show significant differences in outcomes. Notably, hypertension (15), tobacco use (27), and prior site infection (23) did not correlate with worse outcomes. Forty-seven percent of soft tissue infections occurred in the 1 month after implantation, and 76% occurred in the first 4 months. These data provide preliminary insights into risk factors for postoperative complications arising from lower limb osseointegration. These factors are both modifiable (body mass index, center experience), and unmodifiable (sex, age). As this procedure continues to expand in popularity, such results are necessary to inform best practice guidelines and optimize outcomes. Further prospective studies are needed to confirm the above trends.