Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:13 AM
Study NCT ID:
NCT07401095
Status:
RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
Sponsor:
Hancock Orthopedics
Organization:
Study Overview
Official Title:
Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
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:
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.
Detailed Description:
This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using an all-arthroscopic Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:
Control Group: Arthroscopic Broström repair using a suture-anchor construct only.
Treatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant.
Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 1, 3, and 6 weeks, as well as at 3, 6, and 12 months using various patient-reported outcome measures to asses pain, function, activity and safety post surgery.
Control Group: Arthroscopic Broström repair using a suture-anchor construct only.
Treatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant.
Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 1, 3, and 6 weeks, as well as at 3, 6, and 12 months using various patient-reported outcome measures to asses pain, function, activity and safety post surgery.
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?: