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
The result's identifiers
Result code in 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>
Alternative codes found
RIV/00064203:_____/22:10442546 RIV/00216208:11130/22:10442546 RIV/00216224:14110/22:00125638
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language 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
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30211 - Orthopaedics
Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Cartilage
ISSN
1947-6035
e-ISSN
1947-6043
Volume of the periodical
13
Issue of the periodical within the volume
january-march
Country of publishing house
US - UNITED STATES
Number of pages
14
Pages from-to
1-14
UT code for WoS article
000777647800001
EID of the result in the Scopus database
2-s2.0-85127246424