Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT07129694
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT07129694
Study Brief:
Protocol Section:
NCT07129694