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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT02308358
Eligibility Criteria:
Inclusion Criteria:
1. Adults age ≥18 years
2. Femoral condyle osteochondral defect ≥10mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation, defect \<10mm for microfracture treatment
3. Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
4. Must be able and willing to follow a standardized rehabilitation protocol.
5. Must be able to read and understand English or a language for which translated versions of the patient reported questionnaires and Informed consent form are available.
6. Must be able to sign informed consent and must voluntarily sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved subject Informed Consent Form.
Exclusion Criteria:
* 1\. Presence of ipsilateral articular fractures, knee ligament injuries or extensor mechanism injuries
2\. Presence of severe soft tissue injuries around the knee that have required or may require skin grafting or flap coverage.
3\. Presence of a previous below knee amputation
4\. Presence of inflammatory systemic arthritis or disease involving the index joint (i.e. gout)
5\. Is a prisoner
6\. Is receiving workman's compensation
8\. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements
9\. Based on a clinical history, physical examination and/or subject presentation, subject has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02308358
Study Brief:
Protocol Section:
NCT02308358