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Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR
Sponsor: CoreTissue BioEngineering Inc.
Summary
A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
Official title: A Randomized, Multicenter Study Comparing the Safety and Efficacy of CT-ACL001, a Regenerative Ligament, With Standard Treatment in Anterior Cruciate Ligament Reconstruction
Key Details
Gender
All
Age Range
18 Years - 44 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2024-11-25
Completion Date
2027-11
Last Updated
2025-09-30
Healthy Volunteers
No
Conditions
Interventions
Anterior cruciate ligament reconstruction
Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.
Anterior cruciate ligament reconstruction
Single-bundle anterior cruciate ligament reconstruction will be performed using the test device. In addition, single-bundle anterior cruciate ligament reconstruction will also be performed in the control group using autologous knee flexor tendons.
Locations (6)
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan