Меню
Набор скоро начнётся NCT07323875

Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy

Без фазы С лечением Achilles Insertional Tendinopathy Achilles Tendinopathy

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: Single-row repair of the Achilles tendon at its calcaneal insertion, Double-row repair of the Achilles tendon at its calcaneal insertion.
Кому может быть актуально
Состояния в реестре: Achilles Insertional Tendinopathy, Achilles Tendinopathy. Базовые параметры: 18 лет — 75 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Single-Row Versus Double-Row Repair in the Surgical Management of Achilles Insertional Tendinopathy: A Randomized Controlled Trial (STRIDE Trial)

Обзор

Achilles insertional tendinopathy may require surgical debridement and tendon reattachment when non-operative treatment fails. Single-row and double-row repairs are used, with biomechanical studies favoring double-row, but clinical evidence of improved outcomes is lacking and costs are higher. This multi-center randomized trial will use the VISA-A score to compare outcomes and inform cost-effective, evidence-based surgical care.

Подробное описание

Double-row repairs for Achilles insertional tendinopathy have been shown biomechanically to be stronger than single-row repairs, but clinical studies have not demonstrated clear advantages. Existing comparative studies are limited by retrospective designs and use of non-validated outcome measures such as AOFAS, VAS, and SF-36 Physical Function. No prospective randomized trials have evaluated clinical outcomes of single-row versus double-row repairs.

This multi-center randomized controlled trial will use the disease-specific Victorian Institute of Sports Assessment-Achilles (VISA-A) score to compare clinical outcomes between single-row and double-row repairs, providing high-quality evidence to guide optimal surgical management.

Вмешательства

  • Процедура Single-row repair of the Achilles tendon at its calcaneal insertion
    single-row (2 anchors)
  • Процедура Double-row repair of the Achilles tendon at its calcaneal insertion
    double-row (4 anchors)

Первичные конечные точки

  • Disease-specific outcomes [Срок оценки: 24 months after surgery]
Вторичные конечные точки (8)
  • Surgical Cost [Срок оценки: Within 2 hours of surgery]
  • Foot and Ankle Ability Measure (FAAM) [Срок оценки: 24 months after surgery]
  • Visual Analogue Scale Foot and ankle (VAS-FA) [Срок оценки: 24 months after surgery]
  • Plantarflexion strength [Срок оценки: 24 months after surgery]
  • Biomechanical performance [Срок оценки: 24 months after surgery]
  • Functional endurance [Срок оценки: 24 months after surgery]
  • Surgical Time [Срок оценки: During surgery]
  • TENDINopathy Severity Assessment - Achilles (TENDINS-A) [Срок оценки: 24 months after surgery]

Критерии участия

Критерии включения

  • Must be deemed to have capacity to provide informed consent;
  • Must sign and date the informed consent form;
  • Stated willingness to comply with all study procedures;
  • Adult patients between the ages of 18 and 75 years with symptomatic chronic Achilles insertional tendinopathy for a minimum of 3 months
  • Failure of non-operative management (which includes physiotherapy, stretching exercises, heel lifts, nonsteroidal anti-inflammatory drugs (NSAIDs), activity modification, etc.) for at least 3 months.
  • Preoperative imaging (x-ray and Medical Resonance Imaging (MRI)) is available and completed;
  • Willingness of patients to follow the postoperative rehabilitation protocol;
  • Willingness of patients to be available for follow up appointments for up to 2 years.

Критерии исключения

  • Non-insertional Achilles tendinopathy;
  • Achilles tendon rupture;
  • Previous Achilles tendon surgery;
  • Oral steroid use or steroid injection within 3 months of surgery;
  • History of connective tissue or collagen disorder (e.g. Marfan Syndrome)
  • History of chronic inflammatory disorders
  • History of neurological disease (stroke, cerebral palsy)
  • History of using more than 30mg of oxycodone or equivalent per day;
  • Current cigarette smoker (Former smokers must have quit for minimum of one year)
  • Diabetes type I or II
  • Pregnancy
  • Hypersensitivity to metal, Polylactic Acid (PLA), or Polyetheretherketone (PEEK) materials
  • Active infection
  • Worker's compensation claim (e.g. WSIB)
  • History of cognitive or mental health conditions that would make the participant unable to complete study procedures
  • Non-English speaking

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Women's College Hospital — Toronto

Идентификаторы

NCT: NCT07323875 · CTO Study Number:5686

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗