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Clinical Trial

Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability

NCT: NCT06638138 · COMPLETED

NCT IDNCT06638138
StatusCOMPLETED
Start Date2023-08-22
Completion2025-12-03

Brief Summary

The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.

Frequently Asked Questions

What is Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability?

Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability is a clinical trial registered under NCT06638138. Current status: COMPLETED.

What is the status of NCT06638138?

The current status of NCT06638138 (Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability) is: COMPLETED.

When did Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability start?

Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability started on 2023-08-22.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.