Patient-specific metal implants for focal chondral and osteochondral lesions in the knee; excellent clinical results at
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Patient‑specific metal implants for focal chondral and osteochondral lesions in the knee; excellent clinical results at 2 years Johannes Holz1 · Tim Spalding2 · Tarek Boutefnouchet2 · Pieter Emans3 · Karl Eriksson4 · Mats Brittberg5 · Lars Konradsen6 · Clemens Kösters7 · Peter Verdonk8 · Magnus Högström9 · Martin Lind10 Received: 1 June 2020 / Accepted: 14 September 2020 © The Author(s) 2020
Abstract Purpose Surgical treatment options for the management of focal chondral and osteochondral lesions in the knee include biological solutions and focal metal implants. A treatment gap exists for patients with lesions not suitable for arthroplasty or biologic repair or who have failed prior cartilage repair surgery. This study reports on the early clinical and functional outcomes in patients undergoing treatment with an individualised mini-metal implant for an isolated focal chondral defect in the knee. Methods Open-label, multicentre, non-randomised, non-comparative retrospective observational analysis of prospectively collected clinical data in a consecutive series of 80 patients undergoing knee reconstruction with the Episealer® implant. Knee injury and Osteoarthritis Outcome Score (KOOS) and VAS scores, were recorded preoperatively and at 3 months, 1 year, and 2 years postoperatively. Results Seventy-five patients were evaluated at a minimum 24 months following implantation. Two patients had undergone revision (2.5%), 1 declined participation, and 2 had not completed the full data requirements, leaving 75 of the 80 with complete data for analysis. All 5 KOOS domain mean scores were significantly improved at 1 and 2 years (p 5 degrees, joint space narrowing on weight-bearing x-rays and greater than 50% loss of meniscal tissue. Full inclusion and exclusion criteria are detailed in Table 1. Data were collected preoperatively and at 3, 12 and 24 months postoperatively. Baseline demographic and clinical information were recorded, including age, gender, BMI, the American Society of Anaesthesiologists (ASA) score, smoking status, comorbidities, lesion size and location, concomitant knee problems, and prior surgical knee procedures. Clinical outcome forms were completed by the patient on paper or electronically as determined in each centre, and operative data were recorded by the surgeon. Implant failure was defined as development of infection, implant removal and revision. Clinical outcome measures consisted of the Knee injury and Osteoarthritis Outcome Scores (KOOS) and the Visual Analogue Score for pain. Mean overall KOOS4 and individual domain KOOS scores were evaluated against the published minimal clinically important difference (MCID) [40]. Between-group analysis was performed
Table 1 Episealer implants patients selection criteria Inclusion criteria
Exclusion criteria
Age ≥ 18 Focal femoral knee chondral or osteochondral lesion Focal chondral and osteochondral lesions: ICRS III–IVb Symptoms of pain and disability Failed non-operative treatment No radiographic loss of joint space on PA 30° Meniscus volum
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