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NCT07401095 · ClinicalTrials.gov registry record · NA
BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
A NA study of ATFL and Lateral Ankle Instability, sponsored by Hancock Orthopedics.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07401095: Recruiting NA study of ATFL and Lateral Ankle Instability, sponsored by Hancock Orthopedics.
NCT07401095 is a NA study of ATFL and Lateral Ankle Instability that is actively recruiting participants, run by Hancock Orthopedics. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07401095, a NA study of ATFL and Lateral Ankle Instability, is actively recruiting participants, sponsored by Hancock Orthopedics.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.
Primary Outcome
The AOFAS Score is a clinician-based assessment tool that evaluates pain, function, and alignment in patients with foot and ankle disorders. It provides a composite score ranging from 0 to 100, with higher scores indicating better function. The system includes region-specific scales (e.g., ankle-hindfoot, midfoot, hallux) and combines both patient-reported symptoms and objective clinician findings
Conditions Studied
Interventions
- DEVICE Brostrom repair with augmentation
- OTHER Brostrom repair without augmentation
Study Locations (1)
Indiana
- Hancock Orthopedics - Greenfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-12-08 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT07401095 shows while recruiting
NCT07401095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 7 conditions, with ATFL appearing as the primary indexed condition, and to 2 interventions - of which Brostrom repair with augmentation is the first listed.
NCT07401095 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT07401095 about?
NCT07401095 is a clinical study titled "BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair". The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.
What is the current status of trial NCT07401095?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2025-12-08. Estimated completion is 2028-12.
What conditions does trial NCT07401095 study?
This clinical trial studies the following conditions: ATFL, Lateral Ankle Instability, Anterior Talofibular Ligament, Anterior Talofibular Ligament Injury, Brostrom Procedure.
What interventions are being tested in trial NCT07401095?
The interventions under investigation include: Brostrom repair with augmentation (DEVICE), Brostrom repair without augmentation (OTHER).
Who is sponsoring clinical trial NCT07401095?
This trial is sponsored by Hancock Orthopedics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07401095 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07401095's enrollment target sits among peer trials
40 1448th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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