Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation

Status unconfirmed · Not applicable

Conditions studied: Lateral Ankle Instability

In brief

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.

Key facts

Study ID

NCT04770818

Run by

Arthrex, Inc.

People needed

154

Starts

2016-03-10

Expected to finish

2023-03-10

Last updated by the study team

2021-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Illinois Bone & Joint Institute — Chicago, Illinois, United States
• Desert Orthopaedic Center — Las Vegas, Nevada, United States
• Logan Regional Orthopedics — Logan, Utah, United States

Full record on ClinicalTrials.gov

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