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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06662266
Eligibility Criteria:
Inclusion Criteria:
* Patients meeting all of the following criteria will be considered eligible for study participation:
1. Patient has a bone defect in the hindfoot or ankle; and
2. Is requiring fusion using an open surgical technique with supplemental bone graft/substitute; and
3. Fusion site is able to be rigidly stabilized with no more than 3 screws across the fusion site; and
4. Patient is requiring one of the following procedures:
* Ankle joint fusion
* Subtalar fusion
* Calcaneocuboid fusion
* Talonavicular fusion
* Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
* Double fusions (talonavicular and calcaneocuboid joints).
Exclusion Criteria:
* Patient meeting any of the following criteria will be excluded from study participation:
1. Patient is under 18 years of age at the time of consent;
2. Patient has an active (local or systemic) infection or is undergoing adjunctive treatment for infection;
3. Patient has previous fusion surgery of the proposed fusion site;
4. Patient has cognitive disorders or is unable to complete questionnaires or provide consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06662266
Study Brief:
Protocol Section:
NCT06662266