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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT03494660
Eligibility Criteria:
Inclusion Criteria:
* Candidates must meet ALL of the following:
1. Surgeon considers the patient appropriate for the SCP Procedure of the hip.
2. Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray.
3. Subject provides voluntary signature on the IRB approved Informed Consent Form.
4. Subject is at least 18 years of age.
5. Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete outcome forms via email, telephone, in-person or by regular mail.
Exclusion Criteria:
* Candidates will be excluded if they meet ANY of the following:
1. Subject has collapse of subchondral bone.
2. Subject is pregnant at the time of surgery.
3. Subject is incarcerated.
4. Subject is involved in active litigation related to the condition being treated.
5. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03494660
Study Brief:
Protocol Section:
NCT03494660