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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F22%3AE0109557" target="_blank" >RIV/00843989:_____/22:E0109557 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064203:_____/22:10442546 RIV/00216208:11130/22:10442546 RIV/00216224:14110/22:00125638

Výsledek na webu

<a href="https://journals.sagepub.com/doi/pdf/10.1177/19476035221085146" target="_blank" >https://journals.sagepub.com/doi/pdf/10.1177/19476035221085146</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1177/19476035221085146" target="_blank" >10.1177/19476035221085146</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30211 - Orthopaedics

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Cartilage

ISSN

1947-6035

e-ISSN

1947-6043

Svazek periodika

13

Číslo periodika v rámci svazku

january-march

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

14

Strana od-do

1-14

Kód UT WoS článku

000777647800001

EID výsledku v databázi Scopus

2-s2.0-85127246424