Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability

Обзор

The goal of this clinical trial is to compare at 5 years the sporting activity of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability. The main question it aims to answer is: What is the long-term sporting activity status of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability ? Participants will visit the clinic once every year during 5 years for clinical checkup.

Вмешательства

• Процедура Anatomical reconstruction
  Anatomical ligamentoplasty or anatomical reconstruction is performed under arthroscopy. The principle of this method, which lasts around 40 minutes under spinal anaesthetic or general anaesthetic, is to reconstruct the LTFA and sometimes also the LCF, if it has been damaged, using a fragment of the tendon gracilis, located in the thigh, removed through an incision under the knee
• Процедура Broström anatomical repair
  Broström's anatomical repair is performed under arthroscopy. The principle of this method is to tighten and reattach the LTFA using very small anchors, when it is detached from the fibula but not too retracted and still of good quality. If necessary, this may also be accompanied by ligament reinforcement ('gould'), using a fragment of a fibrous structure in the ankle, the extensor retinaculum

Первичные конечные точки

• Sporting activity [Срок оценки: Year 5]

Критерии участия

Критерии включения

• Patient, male or female, aged ≥ 18 years
• Patient with chronic ankle instability defined by:
• A history of trauma including a severe ankle sprain.
• Clinical symptoms persisting for at least 3 months at the time of inclusion: pain, swelling, sensation of 'giving way', sensation of instability, recurrent sprains; Clinical tests (drawer test, varus provocation test) confirming grade III laxity; Imaging results (MRI) confirming clinically suspected ligament damage.
• Patient affiliated to or benefiting from a social security scheme
• French-speaking patient who has signed an informed consent form

Критерии исключения

• Patient with deltoid ligament injury, severe fracture or open trauma
• Patient with insufficient ligament remnant and/or in too poor a condition to allow Broström-type repair.
• Patient with a symptomatic osteochondral lesion
• Patient with ankle hyperlaxity (Beighton score > 3)
• Patient with early ankle arthropathy (Takakura arthritis classification ≥ stage 3)
• Patient with neuromuscular disorders, systemic inflammatory disorders or tumours.
• Patient requiring surgery on both ankles
• Patients with a bony deformity of the ankle or foot on the affected side;
• Patients with professional athlete status
• Patient already included in another study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

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

Франция · 1 центр

• Hôpital Privé Jean Mermoz — Lyon

Идентификаторы

NCT: NCT06945198 · 2024-A02345-42 · 2024-A02345-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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