Microfractures Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: A Multicenter Randomized Controlled Trial

Man Soo Kim, Churl Hong Chun, Joon Ho Wang, Jin Goo Kim, Seung Baik Kang, Jae Doo Yoo, Je Gyun Chon, Myung Ku Kim, Chan Woong Moon, Chong Bum Chang, In Soo Song, Jeong Ku Ha, Nam Yong Choi, Yong In

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

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 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.

Original languageEnglish
Pages (from-to)1612-1624
Number of pages13
JournalArthroscopy - Journal of Arthroscopic and Related Surgery
Volume36
Issue number6
DOIs
StatePublished - Jun 2020

Bibliographical note

Funding Information:
The authors thank Sewon Cellontech for the research grant of this study (grant ID: 03CAR). The authors also thank Prof. Dong Jae Kim (Division of Biostatics, Department of Medical Lifescience, College of Medicine, The Catholic University of Korea) for the statistical analysis and Prof. Won Hee Jee (Department of Radiology, Seoul St. Mary’s Hospital, The Catholic University of Korea ), Young Cheol Yoon (Department of Radiology, Samsung Medical Center, College of Medicine, Sungkyunkwan University of School of Medicine), Ja Young Choi (Department of Radiology, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine), and Yeo Ju Kim (Department of Radiology, Inha University Hospital, Inha University) for assessment of radiographic evaluation.

Funding Information:
The authors thank Sewon Cellontech for the research grant of this study (grant ID: 03CAR). The authors also thank Prof. Dong Jae Kim (Division of Biostatics, Department of Medical Lifescience, College of Medicine, The Catholic University of Korea) for the statistical analysis and Prof. Won Hee Jee (Department of Radiology, Seoul St. Mary's Hospital, The Catholic University of Korea ), Young Cheol Yoon (Department of Radiology, Samsung Medical Center, College of Medicine, Sungkyunkwan University of School of Medicine), Ja Young Choi (Department of Radiology, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine), and Yeo Ju Kim (Department of Radiology, Inha University Hospital, Inha University) for assessment of radiographic evaluation. Institutional review board approval by IRBs of Seoul St. Mary's Hospital, the Catholic University of Korea, Study No. XC13DSMI0025K; Wonkwang University Hospital, Wonkwang University, Study No. WKUH1518; Samsung Medical Center, Sungkyunkwan University of School of Medicine, Study No. 2013-12-094; Seoul Paik Hospital, Inje University, Study No. SIT-2013-424; SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Study No 20131107/26-2013-36/112; Ewha Womans University Mokdong Hospital, Ewha Womans University, Study No. 2013-09-001; Daejeon Sun Hospital, Study No. 03CAR; Inha University Hospital, Inha University, Study No. 2013-02-002 (MD13-02); Bucheon St. Mary's Hospital, The Catholic University of Korea, Study No. HC13DSMI0054; St. Paul's Hospital, The Catholic University of Korea, Study No. XC13DSMI0025P. ClinicalTrials.gov ID: NCT02539030. The authors report the following potential conflicts of interest or sources of funding: This study was funded by Sewon Cellontech. None of the authors have received reimbursements or salary from Sewon Cellontech. None of the authors hold any stocks or shares. Full ICMJE author disclosure forms are available for this article online, as supplementary material.

Publisher Copyright:
© 2019 Arthroscopy Association of North America

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