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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07401095
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years of age at the time of surgery.
2. Able to read, understand and sign the informed consent form.
3. Willing to be available to attend each protocol required visit and complete the study required questionnaires.
4. Scheduled to undergo primary, arthroscopic Brostrom repair.
Exclusion Criteria:
1. Previous Brostrom surgery.
2. Concomitant procedures that would change the post operative course/recovery (i.e. total ankle replacement, OCD repair, foot/ankle osteotomies) as determined by the Investigator.
3. Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator.
4. History of non-compliance with medical treatment or clinical trial participation.
5. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up.
6. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
7. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07401095
Study Brief:
Protocol Section:
NCT07401095