- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04770818
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation
March 12, 2021 updated by: Arthrex, Inc.
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation: A Prospective Randomized Study
Lateral ankle ligament stabilization procedures are well described in the orthopaedic literature.
Although success rates are high, the incidence of recurrent instability is well documented.
In addition, with standard rehabilitation protocols, the timeline to return to sport and functional activities may be prolonged.
The InternalBrace Ligament Augmentation Repair is a safe and reproducible technique using FiberTape® and BioComposite SwiveLock® as an augmentation to a Brostrom procedure.
The InternalBrace Ligament Augmentation repair consists of a FiberTape bridge between two Knotless Swivelock anchors providing a protective reinforcement and allows the surgeon to repair lateral or medial ankle instability and the pain associated with it.
This type of repair can be utilized in acute and chronic ankle sprains.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
It is hypothesized that use of InternalBrace Ligament Augmentation in addition to standard anatomic modified Brostrum repair allows for earlier return to pre-injury level compared to a standard Brostrum procedure.
It is also secondarily hypothesized that intermediate and long term incidence of recurrent instability will be lower with use of internal brace augmentation of standard modified Brostrum lateral ankle ligament reconstruction.
Study Type
Interventional
Enrollment (Anticipated)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60618
- Illinois Bone & Joint Institute
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Nevada
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Las Vegas, Nevada, United States, 89121
- Desert Orthopaedic Center
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Utah
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Logan, Utah, United States, 84341
- Logan Regional Orthopedics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- Subjects that consent to the study
- Ages 18 and older
- Subjects who are candidates for primary ankle instability reconstruction utilizing a standard Brostrum technique
- Able to understand, complete and sign/date the Informed Consent Form (ICF)
Exclusion criteria
- Subjects that are pregnant or planning to become pregnant within 58 weeks after surgery
- Persons with a mental or cognitive disability deemed significant enough that they would not be capable of completing the outcome measures
- Systemic laxity
- Bony correction (i.e. calcaneal osteotomy)
- Major additional tendon surgery such as tenodesis or repair of the peroneal tendon (synovectomy is allowable)
- Major arthroscopic surgery such as treatment of chondral defects, including microfracture (arthroscopic synovectomy and arthroscopically treated osteophyte resection are allowable)
- Revision surgery
- Inadequate tissue for standard Brostrum reconstruction
- Neuropathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Modified Brostrum procedure
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.
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Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability
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Active Comparator: Modified Brostrum procedure with InternalBrace ligament augmentation
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.
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Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability with InternalBrace augmentation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to Work
Time Frame: Subject is called every 2 weeks between 6-26 weeks post-op timepoint and asked when they returned to pre-injury level.
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Subject self-assessment of time of return to pre-injury level.
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Subject is called every 2 weeks between 6-26 weeks post-op timepoint and asked when they returned to pre-injury level.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 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
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The VAS is a validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain (10).
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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
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Veterans Rand (VR-12)
Time Frame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
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The VR-12 is a patient-reported instrument from which physical and mental health component summary scores (Physical Component Score and Mental Component Score) are derived.
The VR-12 items assess physical functioning, role limitations due to physical or mental health problems, pain, energy, mental health, social functioning, and general health.
The United States population average PCS and MCS are both 50 points.
The United States population standard deviation is 10 points.
Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
Change from pre-op and post-operative data collection timepoints will be assessed.
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Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
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Foot and Ankle Ability Measure (FAAM)
Time Frame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
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The FAAM is a self-report measure that assesses physical function of individuals with lower leg, foot, and ankle musculoskeletal disorders.
The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the 21-item Activities of Daily Living Subscale and the 8-item Sports Subscale.
Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'.
Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores.
Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
Change from pre-op and post-operative data collection timepoints will be assessed.
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Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
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Karlsson and Peterson Scoring System
Time Frame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
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TheKarlsson and Peterson Scoring System is a self-report that assesses ankle function.
It is composed of 8 questions with a low score of 0 (low function) and a high score of 100 (high function).
Change from pre-op and post-operative data collection timepoints will be assessed.
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Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years
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Tegner Activity Score
Time Frame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks.
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The Tegner activity scale is a one-item score that grades activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Change from pre-op and post-operative data collection timepoints will be assessed.
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Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks.
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Range Of Motion
Time Frame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks and 1 year.
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Range of motion of joints is measured using an instrument called a goniometer.
Range of Motion will be measured using a goniometer during passive motion in a seated position.
All measurements are from a neutral position.
Normal values for the ankle are 0-50 degrees for plantar flexion and 0-20 degrees for dorsiflexion.
For the foot, normal values are 0--35 degrees for inversion and 0-25 degrees for eversion.
Change from pre-op and post-operative data collection timepoints will be assessed.
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Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks and 1 year.
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Return to Sports
Time Frame: Data collected at the following time points: 6 weeks, 12 weeks and 26 weeks
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Physician assessment of patient's return to sports.
Yes or No response.
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Data collected at the following time points: 6 weeks, 12 weeks and 26 weeks
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Stress X-ray
Time Frame: Data will be collected at Pre-op and 1 year.
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A comparison of change in the anterior drawer and talar tilt.
These findings determine the stability of the ligaments, The anterior drawer is measured in millimeters and the talar tilt is measured in degrees.
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Data will be collected at Pre-op and 1 year.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2016
Primary Completion (Actual)
June 30, 2019
Study Completion (Anticipated)
March 10, 2023
Study Registration Dates
First Submitted
February 2, 2021
First Submitted That Met QC Criteria
February 22, 2021
First Posted (Actual)
February 25, 2021
Study Record Updates
Last Update Posted (Actual)
March 16, 2021
Last Update Submitted That Met QC Criteria
March 12, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 928
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lateral Ankle Instability
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William Beaumont Army Medical CenterUnknownLateral Ankle InstabilityUnited States
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Peking University Third HospitalRecruitingChronic Instability of Ankle Joint | Lateral Ligament Complex Injury of AnkleChina
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University GhentCompletedFunctional Ankle InstabilityBelgium
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Linnaeus UniversityCompletedChronic Ankle InstabilitySweden
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