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Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
Sponsor: Stryker Trauma and Extremities
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
Conditions
Interventions
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