Menu
Enrolling by invitation NCT07129694

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

No phase Interventional Anterior Cruciate Ligament Rupture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anterior cruciate ligament reconstruction, Anterior cruciate ligament reconstruction.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Rupture. Basic parameters: 18 years — 44 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Detailed description

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.

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.

Primary outcome measures

  • Evaluation of IKDC Subjective Score using a dedicated evaluation form [Time frame: 12 months after surgery]
Secondary outcome measures (8)
  • Measurement of Tibial Anterior Translation using a measuring device [Time frame: 12 months after surgery]
  • Evaluation of Donor Site Morbidity using a dedicated evaluation form [Time frame: 1 week, 1 month, 3 months and 6 months after surgery]
  • Measurement of Knee Flexion Strength using a measuring device [Time frame: 3 months, 6 months and 12 months after surgery]
  • Evaluation of TEGNER-Activity-Score using a dedicated evaluation form [Time frame: 6 months and 12 months after surgery]
  • Incidence of additional surgery on the affected side [Time frame: Through 12 months after surgery]
  • Graft rupture rate [Time frame: Through 12 months after surgery]
  • Joint effusion [Time frame: 1 month, 3 months and 6 months and 12 months after surgery]
  • Adverse events/malfunction rates [Time frame: Through 12 months after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Japan · 6 centers
  • Hirosaki University Hospital — Hirosaki
  • Hiroshima University Hospital — Hiroshima
  • Hokkaido University Hospital — Sapporo
  • Kobe University Hospital — Kobe
  • Juntendo University Hospital — Bunkyo-ku
  • Tokyo Women's Medical University Hospital — Shinjuku-ku

Identifiers

NCT: NCT07129694 · CT-ACL001 · jRCT2032240214

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗