Clinical trial NCT04770818: Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation
Official title: Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Ankle Instability
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject is randomized to one of two arms.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Return to Work
timeFrame: Subject is called every 2 weeks between 6-26 weeks post-op timepoint and asked when they returned to pre-injury level.
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 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
measure: Veterans Rand (VR-12)
timeFrame: 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
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 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
measure: Karlsson and Peterson Scoring System
timeFrame: 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
measure: Tegner Activity Score
timeFrame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks.
measure: Range Of Motion
timeFrame: Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks and 1 year.
measure: Return to Sports
timeFrame: Data collected at the following time points: 6 weeks, 12 weeks and 26 weeks
measure: Stress X-ray
timeFrame: Data will be collected at Pre-op and 1 year.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Las Vegas
country: United States
facility: Desert Orthopaedic Center
state: Nevada
city: Logan
country: United States
facility: Logan Regional Orthopedics
state: Utah
Study officials:
References: