Lateral Ankle InstabilityNCT04770818
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation
A study testing Modified Brostrum procedure with Internal Brace Augmentation and Modified Brostrum procedure in people with Lateral Ankle Instability, run by Arthrex, Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Ankle Instability
- What is being tested?
- Modified Brostrum procedure with Internal Brace Augmentation and Modified Brostrum procedure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Mar 2016to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- Revision surgery
- Inadequate tissue for standard Brostrum reconstruction
- Neuropathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Illinois Bone & Joint Institute
Chicago, Illinois, 60618
Desert Orthopaedic Center
Las Vegas, Nevada, 89121
Logan Regional Orthopedics
Logan, Utah, 84341
About this study
Official title: 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.
Read the 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.
- Conditions
- Lateral Ankle Instability
- Being tested
- Modified Brostrum procedure with Internal Brace Augmentation, Modified Brostrum procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Brostrum procedure with Internal Brace AugmentationDevice
Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability with InternalBrace augmentation.
Modified Brostrum procedureDevice
Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability
| Study group | Role | What they receive |
|---|---|---|
| Modified Brostrum procedure | Active comparator | 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. Receives: Device: Modified Brostrum procedure |
| Modified Brostrum procedure with InternalBrace ligament augmentation | Active comparator | 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. Receives: Device: Modified Brostrum procedure with Internal Brace Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Work
Subject self-assessment of time of return to pre-injury level.
Measured: Subject is called every 2 weeks between 6-26 weeks post-op timepoint and asked when they returned to pre-injury level.
Secondary outcomes (8)
Visual Analog Scale (VAS)
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).
Measured: 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
Veterans Rand (VR-12)
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.
Measured: 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
Foot and Ankle Ability Measure (FAAM)
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.
Measured: 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
Karlsson and Peterson Scoring System
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.
Measured: 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
Tegner Activity Score
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.
Measured: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks.
Range Of Motion
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.
Measured: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks and 1 year.
Return to Sports
Physician assessment of patient's return to sports. Yes or No response.
Measured: Data collected at the following time points: 6 weeks, 12 weeks and 26 weeks
Stress X-ray
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.
Measured: Data will be collected at Pre-op and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Mar 2016
- Primary completion30 Jun 2019
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subject is randomized to one of two arms.
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770818
- Sponsor's protocol ID
- 928
- Status last verified
- Mar 2021
- First submitted
- 2 Feb 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04770818
- Acronym / sponsor ID
- 928
- Conditions
- Lateral Ankle Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subject is randomized to one of two arms.
| Arm | Type | Receives |
|---|---|---|
| Modified Brostrum procedure | Active comparator | Device: Modified Brostrum procedureLateral 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. |
| Modified Brostrum procedure with InternalBrace ligament augmentation | Active comparator | Device: Modified Brostrum procedure with Internal Brace AugmentationLateral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Brostrum procedure with Internal Brace AugmentationOpen, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability with InternalBrace augmentation. | Device | Modified Brostrum procedure with InternalBrace ligament augmentation |
| Modified Brostrum procedureOpen, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability | Device | Modified Brostrum procedure |
Primary outcome
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.
Subject self-assessment of time of return to pre-injury level.
8 secondary outcomes
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
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
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
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
Tegner Activity Score
Time frame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks.
Range Of Motion
Time frame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks and 1 year.
Return to Sports
Time frame: Data collected at the following time points: 6 weeks, 12 weeks and 26 weeks
Stress X-ray
Time frame: Data will be collected at Pre-op and 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Brostrum procedure with Internal Brace Augmentation and Modified Brostrum procedure in people with Lateral Ankle Instability, run by Arthrex, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.