Man Soo Kim1, Churl Hong Chun2, Joon Ho Wang3, Jin Goo Kim4, Seung-Baik Kang5, Jae Doo Yoo6, Je-Gyun Chon7, Myung Ku Kim8, Chan Woong Moon9, Chong Bum Chang5, In Soo Song7, Jeong Ku Ha4, Nam Yong Choi10, Yong In11. 1. Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. 2. Department of Orthopaedic Surgery, Wonkwang University Hospital, College of Medicine, Wonkwang University, Iksan, Korea. 3. Department of Orthopaedic Surgery, Samsung Medical Center, College of Medicine, Sungkyunkwan University of School of Medicine, Seoul, Korea. 4. Department of Orthopedic Surgery, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, Korea. 5. Department of Orthopaedic Surgery, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. 6. Department of Orthopaedic Surgery, Ewha Womans University Mokdong Hospital, College of Medicine, Ewha Womans University, Seoul, Korea. 7. Department of Orthopaedic Surgery, Daejeon Sun Hospital, Daejeon, Korea. 8. Department of Orthopaedic Surgery, Inha University Hospital, College of Medicine, Inha University, Incheon, Korea. 9. Department of Orthopaedic Surgery, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea. 10. Department of Orthopaedic Surgery, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. 11. Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. Electronic address: iy1000@catholic.ac.kr.
Abstract
PURPOSE: The purpose of this study was to evaluate the clinical efficacy and safety of treating patients with a cartilage defect of the knee with microfractures andporcine-derived collagen-augmented chondrogenesis technique (C-ACT). METHODS:One hundred participants were randomly assigned to the control group (n = 48, microfracture) or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging (MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping. Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and 20% improvement, minimal clinically important difference (MCID), and patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score. RESULTS:MOCART scores in the investigation group showed improved defect repair and filling (P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at 12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the VAS 20% improvement rate was significantly higher in the investigational group (OR 2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the investigation group demonstrated more than the MCID of KOOS pain from baseline to 1 year postoperatively, with a significant difference between groups (P = .0116). CONCLUSION: In this multicenter randomized trial, the addition of C-ACT resulted in better filling of cartilage defect of the knee joint. LEVEL OF EVIDENCE: Level Ⅰ, Multicenter Randomized Controlled Trial.
RCT Entities:
PURPOSE: The purpose of this study was to evaluate the clinical efficacy and safety of treating patients with a cartilage defect of the knee with microfractures and porcine-derived collagen-augmented chondrogenesis technique (C-ACT). METHODS: One hundred participants were randomly assigned to the control group (n = 48, microfracture) or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging (MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping. Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and 20% improvement, minimal clinically important difference (MCID), and patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score. RESULTS: MOCART scores in the investigation group showed improved defect repair and filling (P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at 12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the VAS 20% improvement rate was significantly higher in the investigational group (OR 2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the investigation group demonstrated more than the MCID of KOOS pain from baseline to 1 year postoperatively, with a significant difference between groups (P = .0116). CONCLUSION: In this multicenter randomized trial, the addition of C-ACT resulted in better filling of cartilage defect of the knee joint. LEVEL OF EVIDENCE: Level Ⅰ, Multicenter Randomized Controlled Trial.
Authors: Robert L Parisien; Michael Constant; Bryan M Saltzman; Charles A Popkin; Christopher S Ahmad; Xinning Li; David P Trofa Journal: Cartilage Date: 2021-05-10 Impact factor: 3.117