Satisfactory survivorship and clinical outcomes up to 10 years after the implantation of a novel personalized metal implant for the treatment of osteochondral lesions of the knee

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OBJECTIVES: Treating knee cartilage lesions in middle-aged patients is challenging, particularly when lesions involve the subchondral bone. Personalized focal arthroplasty implants offer a solution when biological repair is no longer optimal or has failed. These small cobalt-chrome implants, designed using patient-specific magnetic resonance imaging (MRI) data, anatomically restore the damaged area with a custom-fit implant. This observational, single centre, clinical study reports mid-to-long-term outcomes (2-10 years) of a novel personalized focal arthroplasty implant. METHODS: Thirty-four patients (13 women, 21 men) with a mean age of 49.7 years (±6.9; 24-63) underwent implantation of a small metal implant and were followed for at least two years (mean follow-up 49.4 months, range 24-120 months). A single plug was used in 33 patients (23 medial femoral condyle [MFC], 4 lateral femoral condyle [LFC], 6 trochlea), while one received two plugs. Two patients underwent concomitant high tibial osteotomy. In 61.7 ​% of cases, implantation was a revision after failed biological cartilage repair. Clinical scores (VAS, KOOS, IKDC) were recorded at baseline, two years, and final follow-up. Statistical analysis was performed using paired Student's t-tests (p ​< ​0.05). Implant survival was assessed via Kaplan-Meier analysis, with failure defined as implant removal. RESULTS: Statistically significant improvements in all clinical scores (VAS, KOOS, IKDC) were observed between baseline and two years and then remained stable. VAS decreased from 6.6 (±2.1) to 3.1 (±3) at two years (p ​< ​0.001) and then to 2.9 (±3.2) at final follow-up. KOOS Symptoms increased from 57.1 (±21.3) to 77.4 (±20.8) at two years (p ​< ​0.001) and to 75.1 (±22.2) at final follow up, while IKDC improved from 34.9 (±13.9) to 58.2 (±22.7) at two years (p ​< ​0.001) and to 59.5 (±25.7) at final follow up. Three failures occurred, requiring revision to total or unicompartmental knee replacement. Kaplan-Meier survival rate was 91.2 ​%. CONCLUSION: Middle aged patients with osteochondral lesions of the knee benefit from good clinical outcomes, high survival rates, and an excellent safety profile up to 10 years after the implantation of a novel personalized small-metal implant. LEVEL OF EVIDENCE: Level II. TYPE OF STUDY: Prospective cohort study.

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