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Recruiting NCT07401095

BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

No phase Interventional ATFL Lateral Ankle Instability Anterior Talofibular Ligament Anterior Talofibular Ligament Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brostrom repair with augmentation, Brostrom repair without augmentation.
Who it may be relevant to
Registry conditions: ATFL, Lateral Ankle Instability, Anterior Talofibular Ligament, Anterior Talofibular Ligament Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study

Overview

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.

Interventions

  • Device Brostrom repair with augmentation
    Brostrom repair with BioBrace
  • Other Brostrom repair without augmentation
    Brostrom repair without BioBrace

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Previous Brostrom surgery.
  • 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.
  • 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.
  • History of non-compliance with medical treatment or clinical trial participation.
  • 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.
  • Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
  • Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
  • Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hancock Orthopedics — Greenfield

Identifiers

NCT: NCT07401095 · ABBB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗