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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT04211857
Eligibility Criteria:
Inclusion Criteria:
1. Subject received the Round XTENDOBUTTON™ for knee repair, 6 months (-14 Days/+31 Days) prior to enrollment
2. Subject agrees to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form
3. Subject is ≥ 18 years of age or ≤ 60 years of age at the time of surgery.
Exclusion Criteria:
1. Subject is entered in another investigational drug, biologic, or device study
2. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04211857
Study Brief:
Protocol Section:
NCT04211857