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BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

NCT07401095 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Brostrom repair with augmentation

Brostrom repair with BioBrace

OTHER

Brostrom repair without augmentation

Brostrom repair without BioBrace

Sponsors & Collaborators

  • CONMED Corporation

    collaborator INDUSTRY

  • Hancock Orthopedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07401095 on ClinicalTrials.gov