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Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

NCT07708584 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-08-19

No results posted yet for this study

Summary

The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after open non-augmented Broström repair or open Broström repair augmented with the BioBrace Implant.

Conditions

  • Lateral Ankle Instability
  • Chronic Lateral Ankle Instability
  • Brostrom Procedure
  • ATFL
  • Anterior Talofibular Ligament
  • Ankle
  • Bioinductive Implant

Interventions

PROCEDURE

Standard Brostrom Repair

Standard-of-care Brostrom repair for chronic lateral ankle instability

DEVICE

Brostrom repair with augmentation

Brostrom repair with BioBrace

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708584 on ClinicalTrials.gov