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ENROLLING BY INVITATION
NCT06829667

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

Sponsor: Stryker Trauma and Extremities

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

14 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

75

Start Date

2023-10-13

Completion Date

2025-12-30

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

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.

Locations (4)

MORE Foundation

Phoenix, Arizona, United States

KUMC

Kansas City, Kansas, United States

Seaview Orthopaedics

Ocean City, New Jersey, United States

ERLANGER

Chattanooga, Tennessee, United States