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Orthopedic Device

Internal Brace for Ankle Ligament Repair

N/A
Waitlist Available
Led By Blake E Moore, MD
Research Sponsored by Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
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 6month post-operative
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two methods of treating a torn ankle ligament, one with a traditional tight rope and one with an additional repair using an internal brace.

Who is the study for?
This trial is for individuals with specific ankle injuries, such as broken bones or ligament ruptures. Participants must not have had bilateral surgery, any ankle surgery before, smoked, or been in another study within the last 90 days.
What is being tested?
The study compares two treatments for ankle injury repair: traditional tight rope fixation and tight rope fixation augmented with an internal brace. Twenty subjects will be randomly assigned to one of these groups and monitored using imaging technology at the start and six weeks after surgery.
What are the potential side effects?
While the information provided does not specify side effects, typical risks may include pain at the surgical site, swelling, infection risk from surgery, possible damage to nearby nerves or blood vessels during operation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6month post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6month post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Syndesmotic volume
Syndesomotic Volume
Secondary study objectives
36-Item Short Form Survey
Foot and Ankle Outcome Score (FAOS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Tight Rope FixationActive Control1 Intervention
Group II: tight rope fixation w/ AITFL repair augmentation with an internal braceActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic SpecialistsLead Sponsor
Arthrex, Inc.Industry Sponsor
46 Previous Clinical Trials
29,952 Total Patients Enrolled
Blake E Moore, MDPrincipal InvestigatorVann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

Media Library

Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace (Orthopedic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05062265 — N/A
Syndesmotic Injury Research Study Groups: Tight Rope Fixation, tight rope fixation w/ AITFL repair augmentation with an internal brace
Syndesmotic Injury Clinical Trial 2023: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace Highlights & Side Effects. Trial Name: NCT05062265 — N/A
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace (Orthopedic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05062265 — N/A
~5 spots leftby Nov 2025
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