NCT04770818

Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation

Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation: A Prospective Randomized Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Modified Brostrum procedure with Internal Brace Augmentation	Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability with InternalBrace augmentation.
DEVICE	Modified Brostrum procedure	Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability

Timeline

• Start date: 2016-03-10
• Primary completion: 2019-06-30
• Completion: 2023-03-10
• First posted: 2021-02-25
• Last updated: 2021-03-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study