Osteochondral Biopsy Analysis Demonstrates That BST-CarGel Treatment Improves Structural and Cellular Characteristics of Cartilage Repair Tissue Compared With Microfracture
| Autor: | Stéphane Méthot, Michael D. Buschmann, Nicolas Tran-Khanh, Matthew S. Shive, Adele Changoor, Alberto Restrepo, Caroline D. Hoemann, William D. Stanish |
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| Rok vydání: | 2016 |
| Předmět: |
polarized light microscopy
medicine.medical_specialty Medical device Quantitative magnetic resonance imaging Biomedical Engineering Physical Therapy Sports Therapy and Rehabilitation Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Biopsy Immunology and Allergy Medicine biopsy histology: scoring systems Cartilage repair 030203 arthritis & rheumatology 030222 orthopedics medicine.diagnostic_test business.industry 3. Good health Surgery Repair tissue cartilage repair collagen organization business |
| Zdroj: | Cartilage |
| ISSN: | 1947-6035 |
| Popis: | 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 histological parameters were significantly better for the microfracture group. BST-CarGel treatment also resulted in a more organized repair tissue with collagen stratification more similar to native hyaline cartilage, as measured by polarized light microscopy scoring ( P = 0.0003). Conclusion Multiple and independent analyses in this biopsy substudy demonstrated that BST-CarGel treatment results in improved structural and cellular characteristics of repair tissue at 1 year posttreatment compared with microfracture alone, supporting previously reported results by quantitative magnetic resonance imaging. |
| Databáze: | OpenAIRE |
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