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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 is a NA study that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 58 participants.
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.
Interventions
- DEVICE Flexband
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2025-12-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06638138
The ClinicalTrials.gov registry entry for NCT06638138 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stryker Trauma and Extremities, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Flexband is the first listed.
NCT06638138 reports 0 study locations.
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.
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