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ENROLLING BY INVITATION
NCT07129694
NA

Obtain Safety and Effectiveness of CT-ACL001, a Regenerative Ligament Using Biological Tissue, in ACLR

Sponsor: CoreTissue BioEngineering Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

PROCEDURE

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