BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

Part of paid clinical trials in Greenfield, Indiana.

Sponsor
Hancock Orthopedics
Study ID
NCT07401095
Status
Recruiting
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Conditions

  • ATFL
  • Ankle
  • Anterior Talofibular Ligament
  • Anterior Talofibular Ligament Injury
  • Brostrom
  • Brostrom Procedure
  • Lateral Ankle Instability

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brostrom repair with augmentation — DEVICE
    Brostrom repair with BioBrace
  • Brostrom repair without augmentation — OTHER
    Brostrom repair without BioBrace

Study Details

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.

Key Dates

Start date
Dec 8, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Control - Repair Only Group
    Procedure: Standard of care Brostrom repair.
  • Experimental: BioBrace Augment Group
    Brostrom repair with BioBrace

Primary Outcome Measure

American Orthopedic Foot and Ankle Society score (AOFAS) [ Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hancock OrthopedicsGreenfieldIndiana46140
Jay Badell, DPM, MS, FACFAS
[email protected]
317-477-6683

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Hancock Orthopedics· Greenfield, IN