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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-13

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lateral Ankle Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients between and including the age of 14-75 at the time of surgery
* Patients who were diagnosed with lateral ankle instability by physician clinical assessment
* Patients who underwent an ATFL repair with Arthrex InternalBrace augmentation device (does not require an isolated repair)

Exclusion Criteria

* Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol. (Minor microfractures and OCD lesions that do not warrant bone debridements, synovectomies, and bone spur removals are allowed)
* Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
* Patients undergoing a Calcaneal osteotomy
* Patients with less than 6 weeks follow-up
* Patients with incomplete medical records
* Patients with Worker's Compensation Cases
* Any patient with a history of infection of the ankle predating the ankle repair
* Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
* Patients who have a medical history that would likely make the patient an unreliable research participant

Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No