Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07708584
Status
Recruiting
Apply to this trial

Conditions

  • ATFL
  • Ankle
  • Anterior Talofibular Ligament
  • Bioinductive Implant
  • Brostrom Procedure
  • Chronic Lateral Ankle Instability
  • Lateral Ankle Instability

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Brostrom Repair — PROCEDURE
    Standard-of-care Brostrom repair for chronic lateral ankle instability
  • Brostrom repair with augmentation — DEVICE
    Brostrom repair with BioBrace

Study Details

The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after open non-augmented Broström repair or open Broström repair augmented with the BioBrace Implant.

Key Dates

First listed
Jul 16, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

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

Arms

  • Other: Standard Brostrom Repair (SBR)
    Standard-of-care Brostrom repair
  • Experimental: Augmented Brostrom Repair (ABR)
    Brostrom repair augmented with BioBrace

Primary Outcome Measure

Pain VAS [ Time Frame: From enrollment to the last follow-up at 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Christopher Miller, MD
[email protected]
617-525-9382
Massachusetts General HospitalBostonMassachusetts02114
Gregory Waryasz, MD
[email protected]
781-487-4338

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By research site
Brigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

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