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

J 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:

URL

Impact factor

Impact factor: 2.800

RIV identification code

RIV/00216224:14110/22:00125638

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1177/19476035221085146

UT WoS

000777647800001

Keywords in English

autologous chondrocyte implantation; cartilage repair; hydrogel; knee; large defects

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.

Citovat

NIEMEYER, P., M. HANUS, J. BELICKAS, T. LÁSZLÓ, R. GUDAS, M. FIODOROVAS, A. CEBATORIUS, M. PASTUCHA, P. HOZA, K. MAGOS, K. IZADPANAH, Libor PAŠA, G. VÁSÁRHELYI, K. SISÁK, M. MOHYLA, C. FARKAS, O. KESSLER, S. KYBAL, R. SPIRO, A. KÖHLER, A. KIRNER, S. TRATTNIG and C. GAISSMAIER. 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. Cartilage. THOUSAND OAKS: Sage, 2022, vol. 13, No 1, p. 1-14. ISSN 1947-6035. Available from: https://dx.doi.org/10.1177/19476035221085146.

@article{1846397,
   author = {Niemeyer, P. and Hanus, M. and Belickas, J. and László, T. and Gudas, R. and Fiodorovas, M. and Cebatorius, A. and Pastucha, M. and Hoza, P. and Magos, K. and Izadpanah, K. and Paša, Libor and Vásárhelyi, G. and Sisák, K. and Mohyla, M. and Farkas, C. and Kessler, O. and Kybal, S. and Spiro, R. and Köhler, A. and Kirner, A. and Trattnig, S. and Gaissmaier, C.},
   article_location = {THOUSAND OAKS},
   article_number = {1},
   doi = {http://dx.doi.org/10.1177/19476035221085146},
   keywords = {autologous chondrocyte implantation; cartilage repair; hydrogel; knee; large defects},
   language = {eng},
   issn = {1947-6035},
   journal = {Cartilage},
   title = {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},
   url = {https://journals.sagepub.com/doi/10.1177/19476035221085146?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed&},
   volume = {13},
   year = {2022}
}

TY  - JOUR
ID  - 1846397
AU  - Niemeyer, P. - Hanus, M. - Belickas, J. - László, T. - Gudas, R. - Fiodorovas, M. - Cebatorius, A. - Pastucha, M. - Hoza, P. - Magos, K. - Izadpanah, K. - Paša, Libor - Vásárhelyi, G. - Sisák, K. - Mohyla, M. - Farkas, C. - Kessler, O. - Kybal, S. - Spiro, R. - Köhler, A. - Kirner, A. - Trattnig, S. - Gaissmaier, C.
PY  - 2022
TI  - 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
JF  - Cartilage
VL  - 13
IS  - 1
SP  - 1-14
EP  - 1-14
PB  - Sage
SN  - 19476035
KW  - autologous chondrocyte implantation
KW  - cartilage repair
KW  - hydrogel
KW  - knee
KW  - large defects
UR  - https://journals.sagepub.com/doi/10.1177/19476035221085146?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed&
N2  - 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.
ER  -

NIEMEYER, P., M. HANUS, J. BELICKAS, T. LÁSZLÓ, R. GUDAS, M. FIODOROVAS, A. CEBATORIUS, M. PASTUCHA, P. HOZA, K. MAGOS, K. IZADPANAH, Libor PAŠA, G. VÁSÁRHELYI, K. SISÁK, M. MOHYLA, C. FARKAS, O. KESSLER, S. KYBAL, R. SPIRO, A. KÖHLER, A. KIRNER, S. TRATTNIG and C. GAISSMAIER. 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. \textit{Cartilage}. THOUSAND OAKS: Sage, 2022, vol.~13, No~1, p.~1-14. ISSN~1947-6035. Available from: https://dx.doi.org/10.1177/19476035221085146.

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