Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation

NCT04770818 | Unknown FDA Device

• 1 other identifier: 928
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Lateral Ankle Instability

Outcome Measures

Primary Outcomes (1)

• Return to Work

  Subject self-assessment of time of return to pre-injury level.

  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)

  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)

  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)

  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

  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

  Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks.

Study Arms (2)

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.

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.

Device: Modified Brostrum procedure with Internal Brace Augmentation

Interventions

Modified Brostrum procedure with Internal Brace Augmentation DEVICE

Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability with InternalBrace augmentation.

Modified Brostrum procedure with InternalBrace ligament augmentation

Modified Brostrum procedure DEVICE

Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability

Modified Brostrum procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (3)

Illinois Bone & Joint Institute

Chicago, Illinois, 60618, United States

Location

Desert Orthopaedic Center

Las Vegas, Nevada, 89121, United States

Location

Logan Regional Orthopedics

Logan, Utah, 84341, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject is randomized to one of two arms.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 25, 2021
• Study Start: March 10, 2016
• Primary Completion: June 30, 2019
• Study Completion: March 10, 2023
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)