Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study

BACKGROUND: We described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants. METHODS: All consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low- and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up. RESULTS: Ninety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic loosening’s occurred. One individual (OFI-Y) required stoma surgical refashioning due to soft tissue redundancy. At baseline mean ±SD and median (25(th) to 75(th) PCTL) Q-TFA PUS and GS were 52±39, 52(7–90) and 40±19, 42(25–50) and improved significantly to 88±18, 90 (90–100) and 71±15, 75 (67–83) at one-year follow-up. The GS Q3 improved over time. CONCLUSION: Titanium osseointegration implants can be safely used within a one-year follow-up period. The performance improved compared to the use of a socket-suspended prosthesis.