Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT04770818
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2021-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation
Sponsor:
Arthrex, Inc.
Organization:
Study Overview
Official Title:
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation: A Prospective Randomized Study
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: