Minimally Invasive Procedure Versus Conservative Treatment in the Management of Calcaneal Joint Fractures

Обзор

Calcaneal fractures, which affect the heel bone, are the most common type of tarsal fractures and often occur in young people, leading to long recovery times and significant social and economic consequences. Traditional treatments include either non-surgical methods, like immobilizing the foot in a cast, or open surgery, which involves a large incision to fix the bone with plates. However, open surgery has a high complication rate, including issues with wound healing. Recent advances have introduced minimally invasive surgical techniques, which use smaller incisions and have shown better results with fewer complications. This study aims to compare two treatment options for displaced calcaneal fractures: a minimally invasive surgery group and a non-surgical treatment group using a plaster boot. The goal is to determine whether minimally invasive surgery provides better outcomes for patients, such as faster recovery, fewer complications, and improved long-term function, to guide future treatment practices. Thus, this is a prospective, randomised comparative study of the management of articular fractures of the calcaneus: conservative treatment versus minimally invasive surgery.

Вмешательства

• Процедура Minimally invasive surgical application of Calcanail®
  The procedure involves making small incisions to insert a specialized nail into the bone to realign and stabilize the fracture. This approach minimizes damage to surrounding tissues, reduces the risk of wound complications, and allows for quicker recovery compared to traditional open surgery. after surgery, the patient will benefit from an immobilisation with a plaster boot without support for 3 weeks, followed by immobilisation with a removable walking boot for 3 weeks with partial support depe
• Процедура Immobilisation by cast boot
  The patient will be immobilised in a plaster cast without support for 3 weeks, followed by immobilisation in a removable walking boot for 3 weeks with partial support depending on the pain.

Первичные конечные точки

• To show a significant difference in favour of minimally invasive surgical treatment compared with orthopaedic treatment for displaced articular fractures of the calcaneus. [Срок оценки: 1 year follow-up]

Вторичные конечные точки (6)

• Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the rate of early complications (skin problems, infections, complex regional pain syndrome) [Срок оценки: 1 year follow-up]
• Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the rate of late complications (rate of arthrodesis revision) [Срок оценки: 1 year follow-up]
• Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :Improved anatomical relationships (radiological measurements) [Срок оценки: 1 year follow-up]
• Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on : Improved bootability at 1 year. [Срок оценки: 1 year follow-up]
• Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on :A reduction in the time taken to return to work and sport at 1 year. [Срок оценки: 1 year follow-up]
• Demonstrate the superiority of minimally invasive surgical treatment over orthopaedic treatment on : An improvement in the patient self-assessment score (SAV) at 1 year. [Срок оценки: 1 year follow-up]

Критерии участия

Критерии включения

• Patient aged 18 or over
• Patient with a posterior articular fracture of the calcaneus Sanders II to IV, less than 15 days old
• Patient affiliated to a social security scheme,
• Patient having given written consent following written and oral information.

Критерии исключения

• Patient with open calcaneal fracture
• Patient with bilateral calcaneal fracture
• Patient with extreme varus or valgus impingement of the fibula
• Patient with associated talar, tibial, femoral and/or pelvic fracture or associated spinal cord injury.
• Patient unsuitable for loco-regional anaesthesia (LRA).
• Patient with neuro-psychiatric disorders resulting in an inability to follow a post-surgical or post-immobilisation rehabilitation protocol.
• Pregnant women
• Patient protected by law under guardianship or curatorship, or unable to participate in a clinical study under article L. 1121-16 of the French Public Health Code.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06779305 · 24-PP-14

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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