Arginine and Nitric Oxide (NO) Early Prognostic Markers for Non-union Development
Arginine and Nitric Oxide (NO) Metabolism During Bone Healing and Non-union Development- Early Prognostic Markers
Objective: Primary objective is to study the arginine-NO metabolism during fracture healing and dysfunctional fracture healing. Secondary objective: to investigate if differences or decreased arginine and NO concentrations in bone healing form a prognostic marker for non-union development Hypothesis: Early detection of disturbances in the Arginine and nitric oxide metabolism during fracture healing are a good prognostic marker for non-union development.
Study design: Prospective observational study. Study population: All acute fracture patients (age >18 years), with a fracture of the tibia or femur attending the Department of General Surgery, to investigate the Arginine -NO metabolism during normal fracture healing and possible dysfunctional healing. In total 100 patients will be included during this study.
Main study parameters/endpoints:
Primary endpoints are arginine and Nitric Oxide levels in the plasma during normal and dysfunctional fracture healing the bone in patients with and without non-union Secondary endpoints are levels of Nitric Oxide citrulline, ornithine and other amino acids in bone and in plasma Other parameters: baseline demography details will be obtained, including possible confounders, such as bodyweight, smoking, alcohol abuse, which may interfere with the outcome of this study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extent of the burden and risk associated with participation is expected to be low during this study. In total, 7 blood samples will be taken during this study (45ml, in total). During the primary (and possible secondary) surgical procedure, bone debris will be taken. Bone debris is usually discarded but will be used for analysis in this study. There is no extra surgical procedure necessary to obtain the bone debris.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maastricht, Países Bajos, 6229ER
- Reclutamiento
- Maastricht University Medical Center
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Contacto:
- Martijn Poeze, MD, PhD
- Número de teléfono: 6262 +31433871956
- Correo electrónico: m.poeze@ah.unimaas.nl
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Contacto:
- Nina Wijnands, MD, PhD-student
- Número de teléfono: 9115 +3143 3881497
- Correo electrónico: n.wijnands@ah.unimaas.nl
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Investigador principal:
- Martijn Poeze, MD,PhD
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Sub-Investigador:
- nina Wijnands, MD, PhD-student
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Written informed consent
- Age > 18 years
- Patient with a fracture of the femur or tibia for which a surgical procedure providing bone debris is performed as therapy
Exclusion Criteria:
- Patients with another bone fracture in their recent medical history
- Infectious complications, such as infected pseudo-arthrosis
- Use of chronic corticosteroids or nitrovasodilating medication
- Patients with severe metabolic disturbances (liver, and renal insufficiency, diabetes).
- Patients with metastases, haematological malignancies or chemotherapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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normal fracture healing
group in which normal fracture healing has occured
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Sin intervención
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atrophic
patients in which an atrophic non-union occured
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Sin intervención
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hypertrophic
patients in which a hypertrophic non-union occured
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Sin intervención
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The arginine, NO, citrulline and ornithine levels in plasma and bone debris during normal and dysfunctional fracture healing in patients with and without a non-union
Periodo de tiempo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Martijn Poeze, MD, PhD, Maastricht University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MEC-09-2-123
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