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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT07243860
Eligibility Criteria:
Inclusion Criteria:
1. Body Mass Index (BMI) ≥18.5 kg/m² and \<35 kg/m²;
2. Diagnosed with first-time, unilateral, isolated anterior cruciate ligament (ACL) rupture ;
3. No or only mild concomitant injuries to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament;
4. Voluntarily participated in the study and provided written informed consent .
Exclusion Criteria:
1. Patients with ACL rupture for more than 6 months;
2. Combined severe injuries (Grade II or higher) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament(Grading Note: Grade II indicates partial tear with ligament thickening, tortuosity, and fiber disruption; Grade III indicates complete rupture);OR combined severe meniscal tears ;
3. History of prior knee surgery (e.g., meniscal repair, ligament reconstruction, arthroplasty, arthroscopic debridement);
4. Presence of other knee pathologies: knee osteoarthritis, tumors, rheumatoid arthritis, tuberculosis, infectious or inflammatory diseases, fractures, dislocations, or other skeletal injuries;
5. Severe cardiac, pulmonary, cerebral, hepatic, or renal dysfunction; OR visual/cognitive impairments.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07243860
Study Brief:
Protocol Section:
NCT07243860