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NCT06638138 · ClinicalTrials.gov registry record · NA
Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability
A NA study, sponsored by Stryker Trauma and Extremities.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT06638138: Completed NA study, sponsored by Stryker Trauma and Extremities.
NCT06638138 is a NA study that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06638138, a NA study, has completed, sponsored by Stryker Trauma and Extremities.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.
Primary Outcome
The primary outcome measure will be subject reported assessment of time to pre-injury activity level.
Interventions
- DEVICE Flexband
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2025-12-03 |
| Phase | NA |
What the finished NCT06638138 record still lists
NCT06638138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Flexband is the first listed.
NCT06638138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06638138 about?
NCT06638138 is a clinical study titled "Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability". The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAN...
What is the current status of trial NCT06638138?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2023-08-22. Estimated completion is 2025-12-03.
What interventions are being tested in trial NCT06638138?
The interventions under investigation include: Flexband (DEVICE).
Who is sponsoring clinical trial NCT06638138?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06638138's enrollment target sits among peer trials
58 1256th of 2000 higher than 740 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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