Sponsor:
Hancock Orthopedics
Code:
NCT07401095
Conditions
ATFL
Lateral Ankle Instability
Anterior Talofibular Ligament
Anterior Talofibular Ligament Injury
Brostrom Procedure
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Brostrom repair with augmentation
Brostrom repair without augmentation
Brief summary:
Conditions
ATFL
Lateral Ankle Instability
Anterior Talofibular Ligament
Anterior Talofibular Ligament Injury
Brostrom Procedure
Study ID
NCT07401095
Start date
Dec 8, 2025
Status verified date
Jan, 2026
Completion date
Dec, 2028
Anticipated
Primary completion date
Jun, 2028
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
40 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
sham comparator: Control - Repair Only Group
experimental: BioBrace Augment Group
Interventions
Brostrom repair with augmentation
Brostrom repair without augmentation
Primary outcome measure
Central contacts
Locations
Hancock Orthopedics
Recruiting
Greenfield, Indiana, United States, 46140
Contacts
Sponsor
Hancock Orthopedics
Last update posted
Feb 12, 2026
Last verified
Jan, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hancock Orthopedics on 2026-02-12.