NCT06829667

Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability

An Open Label, Single Cohort, Multi-center, Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lateral Ankle Instability

Interventions

Type	Name	Description
DEVICE	Arthrex InternalBrace	Arthrex InternalBrace is composed of a polyethylene/polyester suture tape and knotless bone anchors to provide ligament repair bridging and reinforce ligament strength. There have been conflicting results surrounding the clinical efficacy of its use in lateral ligament reconstruction.

Timeline

• Start date: 2023-10-13
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-02-17
• Last updated: 2025-09-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study