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El ensayo clínico NCT07492212 (FEMFIX) para Total Hip Arthroplasty (THA) está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Comparison of Blood Loss Between Cemented and Uncemented Femoral Stems in Anterior Total Hip Arthroplasty (FEMFIX) 86

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07492212 (FEMFIX) es un estudio intervencionista para Total Hip Arthroplasty (THA). Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 15 de abril de 2026 hasta completar 86 participantes. Dirigido por Clinique du Pré, se espera que finalice el 30 de junio de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen

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...
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Título oficial

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

Condiciones médicas
Total Hip Arthroplasty (THA)
Otros ID del estudio
  • FEMFIX
  • 2025-61-PRM
Número del NCT
NCT07492212
Inicio del estudio (real)
2026-04-15
Última actualización
2026-03-25
Fecha de finalización (estimada)
2028-06-30
Inscripción (prevista)
86
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
hip arthroplasty
implant
blood loss
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalCemented fixation
Total hip replacement with cemented fixation
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, resto...Mostrar más
Comparador activoNon-cemented fixation
Total hip replacement with non-cemented fixation
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 patie...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Total blood loss
Mercuriali formula : Estimated total blood volume × \[Preoperative hematocrit (Ht) - Ht on day 5\] + volume of red blood cells transfused
The day of surgery
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
occurrence of a blood transfusion
Occurrence of perioperative blood transfusion, defined as the administration of any allogeneic or autologous red blood cell units during surgery or within the postoperative hospitalization period.
between day 0 and day 5 after surgery
Surgical revision for hematoma
Occurrence of surgical reintervention due to postoperative hematoma at the operated hip site. This includes any return to the operating room for evacuation of a hematoma within the defined postoperative follow-up period.
Between day 0 and day 5 after surgery
Clinical score Postel Merle d'Aubigné
Assessment of hip function using the Postel-Merle d'Aubigné (PMA) score, which evaluates pain, mobility, and walking ability. Each domain is scored from 0 to 6, with a total score ranging from 0 to 18, where higher scores indicate better function.
2 months, 6 months and 12 months after surhery
Harris Hip score
Assessment of hip function using the Harris Hip Score (HHS), a clinician-based outcome measure evaluating pain, function, absence of deformity, and range of motion. The total score ranges from 0 to 100, with higher scores indicating better hip function.
2 months, 6 months and 12 months after surgery
Oxford score
a validated questionnaire consisting of 12 items related to pain and daily activities. Each item is scored from 0 to 4, with a total score ranging from 0 to 48, where higher scores indicate better outcomes.
2 months, 6 months and 12 months after surgery
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • patient needed a total hip arthroplasty

  • Previous surgery on the affected hip
  • Preoperative anemia
  • Femoral neck fracture
  • Patient with a contraindication to tranexamic acid
  • Pregnant or breastfeeding patient
Clinique du Pré logoClinique du Pré
Contactos centrales del estudio
Contacto: Marion Mandon, PhD, +336 78 27 76 72, [email protected]
2 Centros del estudio en 1 países
Clinique Jeanne d'Arc, Gien, 45500, France
Marion Mandon, PhD, Contacto, +336 78 27 76 72, [email protected]
Clinique du Pré, Le Mans, 72000, France
Marion Mandon, PhD, Contacto, +336 78 27 76 72, [email protected]