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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6month post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6month post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Syndesmotic volume
Syndesomotic Volume
Secondary outcome measures
36-Item Short Form Survey
Foot and Ankle Outcome Score (FAOS)
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
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Who is running the clinical trial?
Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic SpecialistsLead Sponsor
Arthrex, Inc.Industry Sponsor
44 Previous Clinical Trials
29,862 Total Patients Enrolled
Blake E Moore, MDPrincipal InvestigatorVann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an injury or condition that is listed as a part of the study criteria.You are a smoker.You have had surgery on your ankle before.
Research Study Groups:
This trial has the following groups:- Group 1: Tight Rope Fixation
- Group 2: tight rope fixation w/ AITFL repair augmentation with an internal brace
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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