Summary
Using real-world data from 662 knees of 645 patients in Japan, we clarified that the I/III collagen membrane appears safer than the periosteum in covering matrix-associated autologous chondrocyte implantation and is clinically effective in treating large cartilage defects in knee joints for up to 2 years of follow-up.
Abstract
Background
The safety and effectiveness of a synthetic type I/III collagen membrane in covering matrix-associated autologous chondrocyte implantation (cMACI) compared to a periosteum (pMACI) remain unestablished.
Purpose
To clarify the safety and effectiveness of type I/III collagen membrane as a cover for MACI using Japanese real-world data analysis to compare cMACI to pMACI for large (≥4 cm2) cartilage defects in knee joints.
Study design: Multicenter cohort comparative study.
Methods
Data were collected from patients who had undergone cMACI or pMACI in Japan between June 14, 2013, and December 10, 2019, and had follow-up data for two years. Adverse events (AEs), such as graft delamination, hypertrophy, contracture, ossification, and hydrarthrosis, were compared, and the risk ratios (RRs) for cMACI referring to pMACI were calculated. A logistic regression model (LRM) was used to analyze the factors affecting AEs. Kaplan-Meier survival analysis was performed to determine the cumulative treatment failure rate, which is defined as the need for re-operation following cMACI and pMACI. A mixed-effect model for repeated measures compared the improvement in the Lysholm knee scoring scale (LKS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6, 12, and 24 months.
Results
The sample size was 662 knees of 645 patients (mean age, 41.6 years; cMACI/pMACI, 101/561 knees; mean defect size, 6.6 cm2). Graft delamination, hypertrophy, contracture, and ossification were significantly lower in cMACI than in pMACI (5.9%/14.1%, 1.0%/10.7%, 1.0%/8.7%, and 0%/2.3%, respectively), with no difference in hydrarthrosis (12.9%/14.1%). The RRs of delamination, hypertrophy, and contracture in cMACI referring to pMACI were 0.43 (95%CI: 0.19-0.95, p=0.0379) 0.10 (0.01-0.70, p=0.0203), and 0.12 (0.02-0.89, p=0.0374). LRM revealed that age influenced hypertrophy and ossification, with cutoff ages of 32 and 20. Knee contracture was associated with lesion size (OR 1.57 [95%CI: 1.09 - 2.26, p=0.0162]), collagen membrane (0.12 [0.02 - 0.92, p=0.0411]), and meniscal injuries (2.02 [1.06 - 3.85, p=0.0320]), indicating a cutoff value of 7.0 cm2 in lesion size. Both cMACI and pMACI reached a minimal clinically important difference in LKS (80.3%/79.5%) and KOOS (72.7%/70.8%) postoperatively, with no significant differences between them.
Conclusion
The type I/III collagen membrane appears safer than the periosteum in covering MACI, and it is clinically effective in treating large cartilage defects in knee joints for up to 2 years of follow-up.