Detailed Information on Publication Record
2022
Treatment of Large Cartilage Defects in the Knee by Hydrogel-Based Autologous Chondrocyte Implantation: Two-Year Results of a Prospective, Multicenter, Single-Arm Phase III Trial
NIEMEYER, P., M. HANUS, J. BELICKAS, T. LÁSZLÓ, R. GUDAS et. al.Basic information
Original name
Treatment of Large Cartilage Defects in the Knee by Hydrogel-Based Autologous Chondrocyte Implantation: Two-Year Results of a Prospective, Multicenter, Single-Arm Phase III Trial
Authors
NIEMEYER, P., M. HANUS (203 Czech Republic), J. BELICKAS, T. LÁSZLÓ, R. GUDAS, M. FIODOROVAS, A. CEBATORIUS, M. PASTUCHA (203 Czech Republic), P. HOZA (203 Czech Republic), K. MAGOS, K. IZADPANAH, Libor PAŠA (203 Czech Republic, belonging to the institution), G. VÁSÁRHELYI, K. SISÁK, M. MOHYLA (203 Czech Republic), C. FARKAS, O. KESSLER, S. KYBAL, R. SPIRO, A. KÖHLER, A. KIRNER, S. TRATTNIG and C. GAISSMAIER
Edition
Cartilage, THOUSAND OAKS, Sage, 2022, 1947-6035
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30211 Orthopaedics
Country of publisher
United States of America
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
Impact factor
Impact factor: 2.800
RIV identification code
RIV/00216224:14110/22:00125638
Organization unit
Faculty of Medicine
UT WoS
000777647800001
Keywords in English
autologous chondrocyte implantation; cartilage repair; hydrogel; knee; large defects
Tags
International impact, Reviewed
Změněno: 19/7/2022 13:22, Mgr. Tereza Miškechová
Abstract
V originále
Objective: To evaluate the clinical outcome of a hydrogel-based autologous chondrocyte implantation (ACI) for large articular cartilage defects in the knee joint. Design: Prospective, multicenter, single-arm, phase III clinical trial. ACI was performed in 100 patients with focal full-thickness cartilage defects ranging from 4 to 12 cm2 in size. The primary outcome measure was the responder rate at 2 years using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Results: Two years after ACI treatment, 93% of patients were KOOS responders having improved by ≥10 points compared with their pre-operative level. The primary endpoint of the study was met and demonstrated that the KOOS response rate is markedly greater than 40% with a lower 95% CI (confidence interval) of 86.1, more than twice the pre-specified no-effect level. KOOS improvement (least squares mean) was 42.0 ± 1.8 points (95% CI between 38.4 and 45.7). Mean changes from baseline were significant in the overall KOOS and in all 5 KOOS subscores from Month 3 (first measurement) to Month 24 (inclusive) (P < 0.0001). The mean MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) score after 24 months reached 80.0 points (95% CI: 70.0-90.0 points) and 92.1 points in lesions ≤ 5 cm2. Conclusions: Overall, hydrogel-based ACI proved to be a valuable treatment option for patients with large cartilage defects in the knee as demonstrated by early, statistically significant, and clinically meaningful improvement up to 2 years follow-up. Parallel to the clinical improvements, MRI analyses suggested increasing maturation, re-organization, and integration of the repair tissue.