Recruiting

Suture Anchors & BioBrace

Sponsor:

Hancock Orthopedics

Code:

NCT07401095

Conditions

ATFL

Lateral Ankle Instability

Anterior Talofibular Ligament

Anterior Talofibular Ligament Injury

Brostrom Procedure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brostrom repair with augmentation

Brostrom repair without augmentation

Study Details

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.

Conditions

ATFL

Lateral Ankle Instability

Anterior Talofibular Ligament

Anterior Talofibular Ligament Injury

Brostrom Procedure

Study ID

NCT07401095

Start date

Dec 8, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. At least 18 years of age at the time of surgery.
2. Able to read, understand and sign the informed consent form.
3. Willing to be available to attend each protocol required visit and complete the study required questionnaires.
4. Scheduled to undergo primary, arthroscopic Brostrom repair.

Exclusion Criteria:

1. Previous Brostrom surgery.
2. Concomitant procedures that would change the post operative course/recovery (i.e. total ankle replacement, OCD repair, foot/ankle osteotomies) as determined by the Investigator.
3. Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator.
4. History of non-compliance with medical treatment or clinical trial participation.
5. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up.
6. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
7. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Control - Repair Only Group

Procedure: Standard of care Brostrom repair.

experimental: BioBrace Augment Group

Brostrom repair with BioBrace

Interventions

Brostrom repair with augmentation

Brostrom repair with BioBrace

Brostrom repair without augmentation

Brostrom repair without 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 ]
  • Foot Function Index (FFI) [ Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months ]
  • Visual Analog Scale (VAS) [ Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months ]
  • Karlsson-Peterson score [ Time Frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months ]

Central Contacts and Locations

Central contacts

Jay Badell, DPM, MS, FACFAS

317-477-6683JBadell@hancockhealth.org

Locations

Hancock Orthopedics

Recruiting

Greenfield, Indiana, United States, 46140

Contacts

Jay Badell, DPM, MS, FACFAS

317-477-6683JBadell@hancockhealth.org

More Information

Sponsor

Hancock Orthopedics

Last update posted

Feb 12, 2026

Last verified

Jan, 2026

Keywords

  • BioBrace
  • The BioBrace Implant
  • BioBrace Implant
  • ATFL
  • Lateral Ankle Instability
  • CONMED
  • Ankle
  • Ankle Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hancock Orthopedics on 2026-02-12.