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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT04770818
Eligibility Criteria:
Inclusion criteria
* Subjects that consent to the study
* Ages 18 and older
* Subjects who are candidates for primary ankle instability reconstruction utilizing a standard Brostrum technique
* Able to understand, complete and sign/date the Informed Consent Form (ICF)
Exclusion criteria
* Subjects that are pregnant or planning to become pregnant within 58 weeks after surgery
* Persons with a mental or cognitive disability deemed significant enough that they would not be capable of completing the outcome measures
* Systemic laxity
* Bony correction (i.e. calcaneal osteotomy)
* Major additional tendon surgery such as tenodesis or repair of the peroneal tendon (synovectomy is allowable)
* Major arthroscopic surgery such as treatment of chondral defects, including microfracture (arthroscopic synovectomy and arthroscopically treated osteophyte resection are allowable)
* Revision surgery
* Inadequate tissue for standard Brostrum reconstruction
* Neuropathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04770818
Study Brief:
Protocol Section:
NCT04770818