BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Brostrom repair with augmentation
  Brostrom repair with BioBrace
• Другое Brostrom repair without augmentation
  Brostrom repair without BioBrace

Первичные конечные точки

• American Orthopedic Foot and Ankle Society score (AOFAS) [Срок оценки: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months]
• Foot Function Index (FFI) [Срок оценки: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months]
• Visual Analog Scale (VAS) [Срок оценки: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months]
• Karlsson-Peterson score [Срок оценки: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hancock Orthopedics — Greenfield

Идентификаторы

NCT: NCT07401095 · ABBB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗