Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty

Официальное название

Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty - A Prospective, Randomized, Multicenter Study

Обзор

Total hip arthroplasty (THA) yields excellent results. To perform the procedure, the surgeon must make certain decisions, including the choice of fixation method for the femoral implant. This surgery, considered to carry a risk of bleeding, therefore exposes the patient : * to complications: heart attacks, strokes... * to mortality * to transfusion: specific risks, cost, length of hospital stay * to anemia: fatigue, longer recovery time The influence of the femoral fixation method on bleeding and blood loss is often debated, but the literature on the subject is very limited. Our hypothesis is that the method of femoral fixation in THA influences bleeding and blood loss, with a benefit for cemented fixations.

Вмешательства

• Процедура Total hip replacement with cemented fixation
  Total hip arthroplasty performed using cemented fixation of the prosthetic components. A femoral stem and acetabular cup are implanted and secured to the bone using polymethylmethacrylate (PMMA) bone cement. This technique provides immediate mechanical stability and is commonly used in patients with reduced bone quality, such as elderly individuals or those with osteoporosis. The procedure aims to relieve pain, restore joint function, and allow early weight-bearing following surgery.
• Процедура Total hip replacement with non-cemented fixation
  Total hip arthroplasty performed using uncemented (press-fit) fixation of the prosthetic components. The femoral stem and acetabular cup are implanted without cement and rely on biological fixation through bone ingrowth into the implant surface. Initial stability is achieved by press-fit insertion, with long-term fixation depending on osseointegration. This technique is often preferred in younger or more active patients with good bone quality. The procedure aims to relieve pain, restore mobility

Первичные конечные точки

• Total blood loss [Срок оценки: The day of surgery]

Вторичные конечные точки (5)

• occurrence of a blood transfusion [Срок оценки: between day 0 and day 5 after surgery]
• Surgical revision for hematoma [Срок оценки: Between day 0 and day 5 after surgery]
• Clinical score Postel Merle d'Aubigné [Срок оценки: 2 months, 6 months and 12 months after surhery]
• Harris Hip score [Срок оценки: 2 months, 6 months and 12 months after surgery]
• Oxford score [Срок оценки: 2 months, 6 months and 12 months after surgery]

Критерии участия

Критерии включения

• patient needed a total hip arthroplasty

Критерии исключения

• Previous surgery on the affected hip
• Preoperative anemia
• Femoral neck fracture
• Patient with a contraindication to tranexamic acid
• Pregnant or breastfeeding patient

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 · 2 центра

• Clinique Jeanne d'Arc — Gien
• Clinique du Pré — Le Mans

Идентификаторы

NCT: NCT07492212 · 2025-61-PRM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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