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

Abstract: 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.

Trial Registration
NCT03319797; EudraCT No.: 2016-002817-22

Angaben zum Objekt

• Standort: Deutsche Nationalbibliothek Frankfurt am Main
• Umfang: Online-Ressource
• Sprache: Englisch
• Anmerkungen: Cartilage. - 13, 1 (2022) , 19476035221085146, ISSN: 1947-6043

Beteiligte, Orts- und Zeitangaben

• Ereignis: Veröffentlichung
• (wo): Freiburg
• (wer): Universität
• (wann): 2022
• Urheber: Niemeyer, Philipp ; Hanus, Martin ; Belickas, Juozas ; Török, László ; Gudas, Rimtautas ; Fiodorovas, M. ; Cebatorius, Algimantas ; Pastucha, M. ; Hoza, P. ; Magos, Krisztián ; Izadpanah, Kaywan ; Paša, L. ; Vásárhelyi, Gábor ; Sisák, Krisztián ; Mohyla, Marek ; Farkas, Clemens ; Kessler, Oliver ; Kybal, S. ; Spiro, Robert C. ; Köhler, A. ; Kirner, Alexandra ; Trattnig, Siegfried ; Gaissmeier, C.

Weitere Informationen

• DOI: 10.1177/19476035221085146
• URN: urn:nbn:de:bsz:25-freidok-2260416
• Rechteinformation: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Letzte Aktualisierung: 15.08.2025, 07:30 MESZ