| Autor: |
Takehiko Matsushita, Tomoyuki Matsumoto, Daisuke Araki, Kanto Nagai, Yuichi Hoshino, Takahiro Niikura, Atsuhiko Kawamoto, Masahiro J. Go, Shin Kawamata, Masanori Fukushima, Ryosuke Kuroda |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
Asia-Pacific Journal of Sports Medicine, Arthroscopy, Rehabilitation and Technology, Vol 28, Iss , Pp 6-12 (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2214-6873 |
| DOI: |
10.1016/j.asmart.2022.03.004 |
| Popis: |
Background/objective: The purpose of this study was to report the outcomes of a clinical trial conducted in Japan to assess the safety and effectiveness of third-generation autologous chondrocyte implantation (ACI) using IK-01 (CaReS™), which does not require flap coverage, in the treatment of patients with focal cartilage injury of the knee. Methods: This was an open label, exploratory clinical trial. Patients were enrolled between June 2012 and September 2016. The primary endpoint of the study was the International Knee Documentation Committee (IKDC) score at 52 weeks after implantation. The IKDC, Lysholm, and visual analog scale (VAS) scores were evaluated at the time of screening and at 4, 12, 24, 36, and 52 weeks after implantation. Improvements from the baseline scores were evaluated using the equation “(postoperative score) − (preoperative score).” Magnetic resonance imaging (MRI) was performed at 2, 12, 24, and 52 weeks after implantation, and MRI measurements were evaluated using T1 rho and T2 mapping. Results: Nine patients were enrolled in this study and were examined for safety. Product quality did not satisfy the specification in one patient, and bacterial joint infection occurred in one patient. As a result, seven patients were included in the outcome analyses. The mean IKDC score significantly improved from 36.4 preoperatively to 74.1% at 52 weeks after implantation (p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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