← Back to Search

Procedure

Modified Brostrum procedure with InternalBrace ligament augmentation for Lateral Ankle Sprain

N/A
Waitlist Available
Research Sponsored by Arthrex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up data collected at the following time points: pre-operative, 3 weeks, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
Awards & highlights

Study Summary

This trial found that the InternalBrace Ligament Augmentation Repair is a safe and reproducible technique for treating lateral ankle instability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~data collected at the following time points: pre-operative, 3 weeks, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and data collected at the following time points: pre-operative, 3 weeks, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Return to Work
Secondary outcome measures
Ankle
Karlsson and Peterson Scoring System
Range Of Motion
+5 more

Trial Design

2Treatment groups
Active Control
Group I: Modified Brostrum procedure with InternalBrace ligament augmentationActive Control1 Intervention
Lateral ankle ligament stabilization procedure utilizing two 2.4mm BioComposite SutureTaks to repair the ATFL, CFL, lateral ankle capsule and extensor retinaculum with InternalBrace fixation using a 4.75mm BioComposite SwiveLock.
Group II: Modified Brostrum procedureActive Control1 Intervention
Lateral ankle ligament stabilization procedure utilizing two 2.4mm BioComposite SutureTaks to repair the ATFL (anterior talo-fibular ligament), CFL (calcanealfibular ligament), lateral ankle capsule and extensor retinaculum.

Find a Location

Who is running the clinical trial?

Arthrex, Inc.Lead Sponsor
44 Previous Clinical Trials
29,728 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available to take part in this research?

"As per clinicaltrials.gov, this trial is not presently accepting participants. The initial posting was on March 10th 2016 and the last update occured on March 12 2021. Despite its inactivity, there are still 1 other trials recruiting volunteers at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation
2016. "Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04770818.
~17 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top