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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2032240214 | Other Identifier | Japan Registry of Clinical Trials (jRCT) |
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| Name | Class |
|---|---|
| Japan Agency for Medical Research and Development | OTHER_GOV |
| Mediscience Planning, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety evaluation cohort; CT-ACL001 treatment group | Experimental | An acute safety evaluation group that will receive treatment with the test device without randomization: 7 cases |
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| Randomization cohort; CT-ACL001 treatment group | Experimental | Treatment with the test device (test device group): 38 cases |
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| Randomization cohort; autologous tendon treatment group | Active Comparator | Anterior cruciate ligament reconstruction with autologous tendon (knee flexor tendon) (control group): 19 cases |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior cruciate ligament reconstruction | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after surgery |
| Evaluation of Donor Site Morbidity using a dedicated evaluation form |
| Measure | Description | Time Frame |
|---|---|---|
| Thigh Circumference | Regarding the thigh circumference on the affected side, the difference between pre-operative and post-operative measurements one week and two weeks after surgery will be evaluated to be smaller in the test device group compared to the control group. | 1 week and 2weeks after surgery |
| Surgery time |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirosaki University Hospital | Hirosaki | Aomori | 036-8563 | Japan | ||
| Hiroshima University Hospital |
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| Anterior cruciate ligament reconstruction | Procedure | 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. |
|
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) |
| 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. | 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) | 6 months and 12 months after surgery |
| 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. | 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. | 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). | 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. | Through 12 months after surgery |
Evaluate whether the surgical time (test device group and comparison group) of the test device group was shorter than that of the comparison group when the same surgeon performed the surgery. The surgical time was defined as the time from the start of skin incision to the completion of all suturing. |
| At index procedure |
| Evaluation of IKDC Subjective Score using a dedicated evaluation form | Evaluate the non-inferiority of the test device group to the control group using the IKDC Subjective Score. (maximum score: 100 and minimum score: 0, higher scores mean a better outcome) | 24 months after surgery |
| Incidence of additional surgery on the affected side | To assess whether there is a significant difference in the incidence (number) of additional surgeries on the affected side. | 24 months after surgery |
| Graft rupture rate | MRI evaluation will reveal that there is no significant difference in graft rupture rate between the test device group and the comparison group. | 24 months after surgery |
| Measurement of Tibial Anterior Translation using a measuring device | Evaluate whether there is any significant difference between the test device group and the comparison group in the amount of anterior tibial movement compared to the healthy side. | 24 months after surgery |
| Measurement of Knee Flexion Strength using a measuring device | In knee flexion strength evaluation (isometric knee flexion strength ratio to affected side), it is evaluated that the test device group has a higher affected side ratio than the control group. | 24 months after surgery |
| Evaluation of TEGNER-Activity-Score using a dedicated evaluation form | Evaluate whether there is no significant difference in the TEGNER-Activity-Scores between the test device group and the comparison group. (maximum score: 10 and minimum score: 0, higher scores mean a better outcome) | 24 months after surgery |
| Hiroshima |
| Hiroshima |
| 734-8551 |
| Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kobe University Hospital | Kobe | Hyōgo | 650-0017 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-0033 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059549 | Anterior Cruciate Ligament Reconstruction |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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