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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

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

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

Do I qualify?Apply below to find out

Find a Location

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

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

Frequently Asked Questions

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

Am I eligible to participate in this clinical research?

"Eligible participants for this trail must have suffered an ankle sprain and be within the ages of 18-80. Approximately 20 patients are needed to partake in this research project."

Answered by AI

What is the maximum capacity of individuals who will be allowed to participate in this trial?

"Affirmative. Data present on clinicaltrials.gov demonstrates that this medical experiment is in the process of recruiting individuals. It was initially publicized on January 31st 2022 and received its most recent update on February 18th 2022, with a goal to recruit 20 patients from one site."

Answered by AI

Are adults of a certain age eligible to take part in this medical experiment?

"This medical research initiative is seeking participants aged 18 and over, yet younger than 80."

Answered by AI

Is this trial still open to enrollment?

"Affirmative. Clinicaltrials.gov declares that this experiment, initially posted on January 31st 2022, is presently searching for participants. A maximum of 20 volunteers need to be enlisted from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.

Blake E. Moore, MD 2022. "Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05062265.