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NCT06829667 · ClinicalTrials.gov registry record
Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
A clinical trial, sponsored by Stryker Trauma and Extremities.
- Completed
- Registry status
- 103
- Enrollment target
NCT06829667: Completed study, sponsored by Stryker Trauma and Extremities.
NCT06829667 is a clinical trial that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 103 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06829667 has completed, sponsored by Stryker Trauma and Extremities.
- COMPLETED
- Registry status
- 103 participants
- Enrollment target
Study Summary
This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating institutions that have undergone an ATFL reconstruction with Arthrex InternalBrace augmentation who have postoperative hospital or ASC records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.
Primary Outcome
The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability. The assessment of effectiveness will be measured by the rate of complications as defined by those patients that necessitated a return to the OR, including implant failure, symptomatic implant requiring removal, peri-implant fracture, deep wound infection and foreign body reaction
Interventions
- DEVICE Arthrex InternalBrace
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2023-10-13 |
| Est. Completion | 2026-04-08 |
What the finished NCT06829667 record still lists
NCT06829667 is an observational study that tracks outcomes without assigning an intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Arthrex InternalBrace is the first listed.
NCT06829667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06829667 about?
NCT06829667 is a clinical study titled "Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability". This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating in...
What is the current status of trial NCT06829667?
This trial is currently completed. The enrollment target is 103 participants. The study started on 2023-10-13. Estimated completion is 2026-04-08.
What interventions are being tested in trial NCT06829667?
The interventions under investigation include: Arthrex InternalBrace (DEVICE).
Who is sponsoring clinical trial NCT06829667?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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