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:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02913404
Eligibility Criteria:
INCLUSION CRITERIA:
1. between age of 14-40
2. BMI between 18-35
3. have a contralateral healthy knee and within 12 months of grade 3 injury to the ipsilateral ACL
4. no greater than grade 2 injury to MCL or LCL and absence of PCL injury
5. articular cartilage injury grade 2 or lower
6. display a quantitative pivot shift test of \>=3 mm lateral translation or \>8 m/sec\*2, or a side to side difference of 50% or greater
7. Use of a quad tendon graft or BTB graft
EXCLUSION CRITERIA:
* Subjects will have no other injury or disease that will interfere with knee function. Subjects will be of generally good health and will have decided to undergo ACL reconstruction surgery and agreed to participate in the study (following informed consent procedures).
* Potential candidates who do not intend to stay in the Pittsburgh area for a period of at least a year following surgery will be excluded.
* Pregnant females will be excluded. Urine pregnancy tests will be administered by the PI prior to research-related exposure to radiation (CT scan, Biodynamics Lab testing). If these radiation exposures occur on the same date, only one pregnancy test will be administered. If these radiation exposures occur on different dates, a pregnancy test will be administered each date.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
40 Years
Study:
NCT02913404
Study Brief:
Protocol Section:
NCT02913404