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Идёт набор NCT07708584

Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

Без фазы С лечением Lateral Ankle Instability Chronic Lateral Ankle Instability Brostrom Procedure ATFL

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard Brostrom Repair, Brostrom repair with augmentation.
Кому может быть актуально
Состояния в реестре: Lateral Ankle Instability, Chronic Lateral Ankle Instability, Brostrom Procedure, ATFL. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability

Обзор

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.

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 the Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:

Control Group: Open standard Broström repair of the lateral ankle

Treatment Group: Open Broström repair of the lateral ankle using a suture-anchor construct augmented with the BioBrace® Implant.

Both groups will be immobilized for 2 weeks and then will undergo standard accelerated rehabilitation protocols (early weight-bearing and sport-specific training) unless they are not tolerated which will lead to using traditional standard protocols.

Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 2 weeks, 2 months, 6 months, and 12 months using various patient-reported outcome measures to asses pain, function, satisfaction, activity and safety post surgery. Participants will also receive biweekly (every 2 weeks) electronic questionnaires assessing return to sport and return to daily/recreational activity. These biweekly assessments will continue until the participant reports full return to their preoperative level of activity or sport. Participants who do not reach preoperative activity/sport level will continue receiving biweekly questionnaires through the 1 year final visit.

Вмешательства

  • Процедура Standard Brostrom Repair
    Standard-of-care Brostrom repair for chronic lateral ankle instability
  • Устройство Brostrom repair with augmentation
    Brostrom repair with BioBrace

Первичные конечные точки

  • Pain VAS [Срок оценки: From enrollment to the last follow-up at 12 months]
  • PROMIS Scale v2.0 - Pain Intensity 3a [Срок оценки: From enrollment to the last follow-up at 12 months.]
  • NIH Toolbox Pain Interference CAT Ages 18 v3.0 [Срок оценки: From enrollment to the last follow-up at 12 months.]
  • PROMIS Scale v1.2 - Global Mental 2a [Срок оценки: From enrollment to the last follow-up at 12 months.]
  • PROMIS Scale v1.2 - Global Physical 2a [Срок оценки: From enrollment to the last follow-up at 12 months.]
  • Foot and Ankle Outcome Score (FAOS) [Срок оценки: From enrollment to the last follow-up at 12 months.]
  • Foot and Ankle Ability Measure Scored [Срок оценки: From enrollment to last follow-up at 12 months.]
  • Clinical Assessment [Срок оценки: From enrollment to the last follow-up at 12 months.]
Вторичные конечные точки (1)
  • Return to Activity [Срок оценки: From baseline until participants report full return to activity or until last follow-up at 12 months.]

Критерии участия

Критерии включения

  • Age 18-65 years
  • Chronic lateral ankle instability (>3 months) confirmed by clinical examination (positive anterior drawer test or talar tilt >10°) and imaging (stress X-ray or MRI).
  • No prior ankle surgery on the affected limb.
  • Willingness to follow postoperative visits and rehabilitation protocols and filling out the patient reported outcome measures (PROMs) forms.

Критерии исключения

  • BMI>40
  • Significant secondary procedures done at the time of repair, including micro-fracture, or any other treatment of osteochondral lesions of the talus or tibia.
  • Concomitant deltoid ligament insufficiency.
  • Any worker's compensation case or any subject with a history of infection of the ankle predating the ankle repair. Current orthopedic issues, not related to the ankle, that prevented the patient from performing the functional tests.
  • Concomitant osteochondral lesions, significant degenerative changes, or severe varus/valgus deformity, neuromuscular disorders or non-adherence concerns.
  • Pregnant
  • Diagnosis of Ehlers-Danlos Syndrome or other connective tissue / hyperlaxity disorder.
  • Prior revision ankle ligament surgery on the affected limb (any revision Broström or lateral ligament reconstruction).

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 · 2 центра
  • Massachusetts General Hospital — Boston
  • Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT07708584 · 2026P000101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗