Bone-anchored prostheses for lower limb amputation in a French cohort with 1-15 years of follow-up: implant survival rates, mechanical complications, and reported outcomes.

PURPOSE: To evaluate the implant survival rate, mechanical complications, and reported patient outcomes of bone-anchored prostheses for patients with lower limb amputation in France after 1-15 years of follow-up. METHODS: This retrospective cohort study included patients who underwent surgery at a single center in France between 2007 and 2021. The primary outcomes were the implant survival rate and functional scores assessed by the Questionnaire for Transfemoral Amputees (Q-TFA). Secondary outcomes were adverse events that occurred during follow-up. RESULTS: The cohort consisted of 20 bone-anchored prostheses in 17 patients. The main level of amputation was transfemoral (82%, n = 14). The main reason for amputation was trauma (n = 15). The mean age at amputation was 32 (range 15-54) years, and the mean age at the first stage of osseointegration was 41 (range 21-58) years. The Kaplan-Meier survival curve showed respective survival rates of 90%, 70%, and 60% at 2, 10, and 15 years. All Q-TFA scores were significantly improved at last the follow-up. Eleven patients (65%) experienced mechanical complications. In total, 37 infectious events occurred in 13 patients (76%), mainly comprising stage 1 infections (68%, n = 25). Only two cases of septic loosening occurred (12%), leading to implant removal. CONCLUSION: This is the first French cohort of bone-anchored prostheses and among the series with the longest follow-up periods. The findings indicate that bone-anchored prostheses are safe and reliable for amputee patients who have difficulties with classic prostheses.

Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial.

BACKGROUND: Randomized controlled trials studying the efficacy and safety of matrix-applied characterized autologous cultured chondrocytes (MACI) versus microfracture (MFX) for treating cartilage defects are limited. PURPOSE: To compare the clinical efficacy and safety of MACI versus MFX in the treatment of patients with symptomatic cartilage defects of the knee. STUDY DESIGN: Randomized controlled clinical trial; Level of evidence, 1. METHODS: Patients enrolled in the SUMMIT (Demonstrate the Superiority of MACI implant to Microfracture Treatment) trial had ≥1 symptomatic focal cartilage defect (Outerbridge grade III or IV; ≥3 cm(2)) of the femoral condyles or trochlea, with a baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) pain value <55. The co-primary efficacy endpoint was the change in the KOOS pain and function subscores from baseline to 2 years. Histological evaluation and magnetic resonance imaging (MRI) assessments of structural repair tissue, treatment failure, the remaining 3 KOOS subscales, and safety were also assessed. RESULTS: Of the 144 patients treated, 137 (95%) completed the 2-year assessment. Patients had a mean age of 33.8 years and a mean lesion size of 4.8 cm(2). The mean KOOS pain and function subscores from baseline to 2 years were significantly more improved with MACI than with MFX (pain: MACI, 37.0 to 82.5 vs MFX, 35.5 to 70.9; function: MACI, 14.9 to 60.9 vs MFX, 12.6 to 48.7; P = .001). A significant improvement in scores was also observed on the KOOS subscales of activities of daily living (MACI, 43.5 to 87.2 vs MFX, 42.6 to 75.8; P < .001), knee-related quality of life (MACI, 18.8 to 56.2 vs MFX, 17.2 to 47.3; P = .029), and other symptoms (MACI, 48.3 to 83.7 vs MFX, 44.4 to 72.2; P < .001) for patients treated with MACI compared with MFX. Repair tissue quality was good as assessed by histology/MRI, but no difference was shown between treatments. A low number of treatment failures (nonresponders: MACI, 12.5% vs MFX, 31.9%; P = .016) and no unexpected safety findings were reported. CONCLUSION: The treatment of symptomatic cartilage knee defects ≥3 cm(2) in size using MACI was clinically and statistically significantly better than with MFX, with similar structural repair tissue and safety, in this heterogeneous patient population. Moreover, MACI offers a more efficacious alternative than MFX with a similar safety profile for the treatment of symptomatic articular cartilage defects of the knee.