Outcomes After a Single-Stage Procedure for Cell-Based Cartilage Repair A Prospective Clinical Safety Trial With 2-year Follow-up

Background: There are currently several approaches being pursued to treat focal defects of articular cartilage, each having specific advantages or challenges. A single-stage procedure that uses autologous cartilage fragments, Cartilage Autograft Implantation System (CAIS), is being evaluated in patients and may offer a clinically effective option.Purpose: To establish the safety of CAIS and to test whether CAIS improves quality of life by using standardized outcomes assessment tools.Study Design: Randomized controlled trial; Level of evidence, 2.Methods: Patients (n = 29) were randomized (1:2) with the intent to treat with either a control (microfracture [MFX]) or an experimental (CAIS) procedure. Patients were followed at predetermined time points for 2 years using several standardized outcomes assessment tools (SF-36, International Knee Documentation Committee [IKDC], Knee injury and Osteoarthritis Outcome Score [KOOS]). Magnetic resonance imaging was performed at baseline, 3 weeks, and 6, 12, and 24 mo...