Purpose: Managing focal cartilage injuries in the middle-aged patient poses a challenge. Focal prosthetic inlay resurfacing has been proposed to be a bridge between biologics and conventional joint arthroplasty. Patient selection and accurate implant positioning is crucial to avoid increased contact pressure to the opposite cartilage surface. A customized femoral condyle implant for focal cartilage injuries was designed to precisely fit each patient’s individual size and location of damage. The primary objective was to assess implant safety profile, surgical usability of the implant and instruments, and implant migration with radiostereometric analysis (RSA). Methods: Ten patients 36–56 years with focal chondral defects, ICRS 3–4 of the femoral cartilage and failed earlier conservative or surgical interventions with VAS pain > 40. The patients were followed for 2 years with subjective outcome measures (VAS, EQ5D, KOOS) and RSA. The customized implant and guide instruments were manufactured by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques using MRI data. Results: VAS, EQ5D and KOOS showed improvements that reached significance for VAS (p ≤ 0.001), Tegner (p = 0.034) and the KOOS subscores ADL (p = 0.0048), sport and recreation (p = 0.034) and quality of life (p = 0.037). VAS and KOOS scores improved gradually at 3, 6 and 12 months. The improvements in EQ5D, KOOS pain and KOOS symptoms did not reach statistical significance. No infections, deep venous thrombosis or other complications occured in the postoperative period. No radiographic signs of damage to the opposing tibial cartilage was noted. The surgical usability of implants and instruments were good. RSA did not show any implant migration. Conclusion: This is the first clinical report of a new customized, focal knee resurfacing system. The short-term implant safety and patient-related outcome measures showed good-to-excellent results. Level of evidence: Prospective case series, Level 4.
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