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Journal of Orthopaedics and Traumatology
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Open Access 01-12-2024 | Osteoarthrosis | Original article

Biphasic cartilage repair implant versus microfracture in the treatment of focal chondral and osteochondral lesions of the knee: a prospective, multi-center, randomized clinical trial

Authors: Tzu-Hao Tseng, Chao-Ping Chen, Ching-Chuan Jiang, Pei-Wei Weng, Yi-Sheng Chan, Horng-Chaung Hsu, Hongsen Chiang

Published in: Journal of Orthopaedics and Traumatology | Issue 1/2024

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Abstract

Background

Autologous minced cartilage is a method for cartilage defect repair, and our study focuses on a newly developed biphasic cylindrical osteochondral construct designed for use in human knees. We aimed to compare its clinical effectiveness and safety with microfracture, the commonly utilized reparative treatment for knee chondral or osteochondral defects.

Materials and methods

Conducted as a prospective multicenter, randomized controlled, non-inferiority trial across nine hospitals, the study involved 92 patients with International Cartilage Repair Society (ICRS) grade 3 to 4 chondral or osteochondral lesions on femoral condyles. Patients were evenly randomized to receive either the biphasic cartilage-repair implant (BiCRI) or microfracture. Functional outcomes and safety assessments were conducted at postoperative intervals of 6 weeks and 3, 6, and 12 months. Primary and secondary endpoints included International Knee Documentation Committee (IKDC) 2000 Subjective Knee Evaluation Form score improvement, the grade distribution in the IKDC 2000 Knee Examination Form, and various assessments, such as the Knee Injury and Osteoarthritis Outcome Score (KOOS), visual analog scales (VASs) for pain, MRI findings, and arthroscopic findings at 12 months.

Results

Out of the initial participants, 47 in the BiCRI group and 45 in the microfracture group completed the follow-up. At 12 months, the mean change in IKDC total score was 25.56 ± 18.48 for BiCRI and 27.51 ± 23.65 for microfracture. The 95% confidence interval (CI) for the score difference (BiCRI minus microfracture) was − 6.95, exceeding the non-inferiority margin of − 12. Secondary endpoints indicated comparable functional outcomes, and arthroscopic findings demonstrated more fully regenerated cartilage in the BiCRI group.

Conclusion

Based on the IKDC 2000 Subjective Knee Evaluation Form score, BiCRI proved non-inferior to microfracture at 12 months. Short-term functional outcomes were comparable to those with microfracture, while arthroscopic findings showed more complete cartilage regeneration in the BiCRI group. Consequently, BiCRI emerges as a viable alternative for treating chondral or osteochondral defects.

Level of evidence

Level 2, multi-center, randomized clinical trial.
Trial registration: Name of the registry: ClinicalTrials.gov. Trial registration number: NCT01477008. Date of registration: 11/14/2011. URL of trial registry record: clinicaltrials.gov/study/NCT01477008
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Metadata
Title
Biphasic cartilage repair implant versus microfracture in the treatment of focal chondral and osteochondral lesions of the knee: a prospective, multi-center, randomized clinical trial
Authors
Tzu-Hao Tseng
Chao-Ping Chen
Ching-Chuan Jiang
Pei-Wei Weng
Yi-Sheng Chan
Horng-Chaung Hsu
Hongsen Chiang
Publication date
01-12-2024
Publisher
Springer International Publishing
Published in
Journal of Orthopaedics and Traumatology / Issue 1/2024
Print ISSN: 1590-9921
Electronic ISSN: 1590-9999
DOI
https://doi.org/10.1186/s10195-024-00802-1

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