Osteochondral Biopsy Analysis Demonstrates That BST-CarGel Treatment Improves Structural and Cellular Characteristics of Cartilage Repair Tissue Compared With Microfracture

作者：Stéphane Méthot, Adele Changoor, Nicolas Tran‐Khanh, Caroline D. Hoemann, William David Stanish, Alberto Restrepo, Matthew S. Shive, Michael D. Buschmann · 发表于：Cartilage · 年份：2015 · DOI：10.1177/1947603515595837 · 被引用次数：54 · 研究领域：Osteoarthritis Treatment and Mechanisms、Lower Extremity Biomechanics and Pathologies、Knee injuries and reconstruction techniques

OBJECTIVE: The efficacy and safety of BST-CarGel, a chitosan-based medical device for cartilage repair, was compared with microfracture alone at 1 year during a multicenter randomized controlled trial (RCT) in the knee. The quality of repair tissue of osteochondral biopsies collected from a subset of patients was compared using blinded histological assessments. METHODS: The international RCT evaluated repair tissue quantity and quality by 3-dimensional quantitative magnetic resonance imaging as co-primary endpoints at 12 months. At an average of 13 months posttreatment, 21/41 BST-CarGel and 17/39 microfracture patients underwent elective second look arthroscopies as a tertiary endpoint, during which ICRS (International Cartilage Repair Society) macroscopic scoring was carried out, and osteochondral biopsies were collected. Stained histological sections were evaluated by blinded readers using ICRS I and II histological scoring systems. Collagen organization was evaluated using a polarized light microscopy score. RESULTS: BST-CarGel treatment resulted in significantly better ICRS macroscopic scores (P = 0.0002) compared with microfracture alone, indicating better filling, integration, and tissue appearance. Histologically, BST-CarGel resulted in a significant improvement of structural parameters-Surface Architecture (P = 0.007) and Surface/Superficial Assessment (P = 0.042)-as well as cellular parameters-Cell Viability (P = 0.006) and Cell Distribution (P = 0.032). No histologi...