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Enrolling by Invitation

NCT Number: NCT07129694

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

A randomized, multicenter study comparing the safety and efficacy of CT-ACL001, a regenerative ligament, with standard treatment in anterior cruciate ligament reconstruction

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hirosaki University Hospital, Hirosaki, Aomori, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years old or older and under 45 years old.
  • Patients with anterior cruciate ligament injury who are candidates for reconstruction surgery.

Exclusion criteria

  • Chronic anterior cruciate ligament injury (injury occurred more than 12 months ago).
  • History of knee surgery, including anterior cruciate ligament surgery on the index side.
  • Complication or history cruciate ligament injury on the opposite side, history of total knee arthroplasty, osteotomy around the knee, or osteosynthesis around the knee on the opposite side.
  • Meniscus injury that requires extensive resection and is impossible to suture on the index side, collateral ligament injury or posterior cruciate ligament injury of 2° or more on the index side.
  • Complication of osteoarthritis of the knee on the index side, KL classification 2° or higher.
  • Complications of cartilage damage that cannot be treated by drilling or microfracture on the index side.
  • Patients with infection in the index knee or inflammatory joint disease such as rheumatoid arthritis.
  • Patients undergoing radiation therapy, chemotherapy, or both.
  • Patients currently receiving treatment with systemic steroids, immunosuppressants, or both.
  • Patients who are allergic to bovine products (e.g. meat).
  • Patients who cannot discontinue returning to sports until 9 months after reconstruction surgery.
  • Pregnant, breastfeeding and possibly pregnant patients.
  • Female patients of childbearing potential and male patients who cannot agree to contraception for at least one year after reconstruction surgery.
  • Patients who participated in other clinical trials within 4 weeks prior to reconstruction surgery.

Treatment and study plan

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.

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.

Primary outcomes

  1. Evaluation of IKDC Subjective Score using a dedicated evaluation form

    Time frame: 12 months after surgery

    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)

Secondary outcomes

  1. Measurement of Tibial Anterior Translation using a measuring device

    Time frame: 12 months after surgery

    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.

  2. Evaluation of Donor Site Morbidity using a dedicated evaluation form

    Time frame: 1 week, 1 month, 3 months and 6 months after surgery

    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)

  3. Measurement of Knee Flexion Strength using a measuring device

    Time frame: 3 months, 6 months and 12 months after surgery

    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.

  4. Evaluation of TEGNER-Activity-Score using a dedicated evaluation form

    Time frame: 6 months and 12 months after surgery

    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)

  5. Incidence of additional surgery on the affected side

    Time frame: Through 12 months after surgery

    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.

  6. Graft rupture rate

    Time frame: Through 12 months after surgery

    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.

  7. Joint effusion

    Time frame: 1 month, 3 months and 6 months and 12 months after surgery

    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).

  8. Adverse events/malfunction rates

    Time frame: Through 12 months after surgery

    Evaluate all adverse events and malfunctions that occur after IC has been obtained and during the clinical trial period.

Other outcomes

  1. Thigh Circumference

    Time frame: 1 week and 2weeks after surgery

    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.

  2. Surgery time

    Time frame: At index procedure

    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.

  3. Evaluation of IKDC Subjective Score using a dedicated evaluation form

    Time frame: 24 months after surgery

    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)

  4. Incidence of additional surgery on the affected side

    Time frame: 24 months after surgery

    To assess whether there is a significant difference in the incidence (number) of additional surgeries on the affected side.

  5. Graft rupture rate

    Time frame: 24 months after surgery

    MRI evaluation will reveal that there is no significant difference in graft rupture rate between the test device group and the comparison group.

  6. Measurement of Tibial Anterior Translation using a measuring device

    Time frame: 24 months after surgery

    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.

  7. Measurement of Knee Flexion Strength using a measuring device

    Time frame: 24 months after surgery

    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.

  8. Evaluation of TEGNER-Activity-Score using a dedicated evaluation form

    Time frame: 24 months after surgery

    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)

Sponsors and collaborators

Lead sponsor

CoreTissue BioEngineering Inc.

Industry

Collaborators

  • Japan Agency for Medical Research and Development
  • Mediscience Planning, Inc.

Registry information

Official study title

A Randomized, Multicenter Study Comparing the Safety and Efficacy of CT-ACL001, a Regenerative Ligament, With Standard Treatment in Anterior Cruciate Ligament Reconstruction

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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