A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction
The study will target patients (18 years old or older and under 45 years old) who have suffered anterior cruciate ligament injuries that require reconstruction surgery, and will evaluate the safety and efficacy of the investigational device when used in reconstruction surgery, using patients who used autologous tendons (knee flexor tendons) as a comparison control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
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.
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.
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Evaluation of IKDC Subjective Score using a dedicated evaluation form
The non-inferiority of the test device group to the control group will be evaluated 12 months after surgery using the IKDC Subjective Score. (maximum score: 100 and minimum score: 0, higher scores mean a better outcome)
Time frame: 12 months after surgery
Measurement of Tibial Anterior Translation using a measuring device
Evaluate whether there is any significant difference in the amount of anterior tibial movement between the test device group and the comparison group 12 months after surgery.
Time frame: 12 months after surgery
Evaluation of Donor Site Morbidity using a dedicated evaluation form
Donor site morbidity will be evaluated to determine whether the test device group is superior to the control group at 1 week, 1 month, 3 months, and 6 months after surgery. (maximum score: 96 and minimum score: 0, higher scores mean a better outcome)
Time frame: 1 week, 1 month, 3 months and 6 months after surgery
Measurement of Knee Flexion Strength using a measuring device
In knee flexion strength evaluation (isometric knee flexion strength ratio of affected side: affected side/healthy side (%)), evaluate whether the affected side ratio is greater in the test device group than in the control group at 3 months, 6 months, and 12 months after surgery.
Time frame: 3 months, 6 months and 12 months after surgery
Evaluation of TEGNER-Activity-Score using a dedicated evaluation form
Evaluate whether there are any significant differences in TEGNER-Activity-Scores between the test group and the comparison group at 6 and 12 months after surgery. (maximum score: 10 and minimum score: 0, higher scores mean a better outcome)
Time frame: 6 months and 12 months after surgery
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Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Incidence of additional surgery on the affected side
To evaluate whether there is a significant difference in the incidence (number) of additional surgeries on the affected side up to 12 months after surgery.
Time frame: Through 12 months after surgery
Graft rupture rate
Evaluate using MRI (T1, T2) to determine whether there is a significant difference in the graft rupture rate between the test device group and the comparison group up to 12 months after surgery.
Time frame: Through 12 months after surgery
Joint effusion
Evaluate whether there is any significant difference between the test device group and the comparison group in the incidence of joint effusion requiring puncture (1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery).
Time frame: 1 month, 3 months and 6 months and 12 months after surgery
Adverse events/malfunction rates
Evaluate all adverse events and malfunctions that occur after IC has been obtained and during the clinical trial period.
Time frame: Through 12 months after surgery