Good subjective outcome and low risk of revision surgery with a novel customized metal implant for focal femoral chondral lesions at a follow-up after a minimum of 5 years

BACKGROUND AND PURPOSE: Patients with focal cartilage lesions experience functional impairment. Results for biological treatments in the middle-aged patient is poor. Previous studies with focal prosthetic inlay resurfacing have shown a higher risk of conversion to total knee replacement at mid-term follow-up. A novel customized implant (Episealer, Episurf, Stockholm, Sweden) has been proposed to improve implant positioning and survival. The primary objective was to assess subjective-, objective function and implant survival at a minimum of five years after surgery. MATERIALS AND METHODS: The inclusion criteria were patients aged 30–65 years with symptomatic focal chondral defects in the medial femoral condyle, International Cartilage Research Society grade 3 or 4 and failed conservative or surgical treatment. Minimum follow-up of 5 years. Clinical and radiologic assessments were made. Patient-reported outcome measurements at the latest follow-up were compared with the baseline data for the Knee injury and Osteoarthritis Outcome Score (KOOS), the EuroQoL (EQ-5D), the Tegner Activity Scale and a Visual Analog Scale of pain (VAS 0–10). RESULTS: Ten patients with the mean follow-up period of 75 months (60–86 months, SD 10) were included. Signs of osteoarthritis were seen in one patient (Ahlbäck 1). No cases with revision to knee replacement. VAS for pain and KOOS showed improvements that reached significance for VAS (p ≤ 0.001) and the KOOS subscores Pain (p = 0.01), ADL (p = 0.003), Sport and Recreation (p = 0.024) and Quality of Life (p = 0.003). CONCLUSION: A good subjective outcome, a low risk of progression to degenerative changes and the need for subsequent surgery were seen at the mid-term follow-up with this customized focal knee-resurfacing implant. LEVEL OF EVIDENCE: Prospective case series, level 4.