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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT00529958
Eligibility Criteria:
Inclusion Criteria:
A confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following:
* History of a traumatic injury episode
* Physical examination findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)
* A positive pivot shift test
* X-rays showing skeletal maturity (ie: tibial tubercle fused) and no fractures. (NB: Magnetic resonance imaging is not required)
* Age 14-50 years old
Exclusion Criteria:
* Patients with combined ligament deficiencies (Posterior Cruciate, Medial and/or Lateral Collateral deficiency.) (NB: Grade 1 side to side differences (ie. \< 5mm) on valgus, varus or posterior stress testing will not be considered exclusions)
* Intra-operative identification of International Cartilage Repair Society (ICRS) Grade 4 chondral lesion of \> 1 cm ² \[61\]
* Previous ligament surgery on the affected or contralateral knees
* Cases involving litigation or Worker's Compensation
* Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfans)
* X-ray showing that tibial physis is not fused
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
50 Years
Study:
NCT00529958
Study Brief:
Protocol Section:
NCT00529958