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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Maastricht, Pays-Bas, 6229ER
- Recrutement
- Maastricht University Medical Center
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Contact:
- Martijn Poeze, MD, PhD
- Numéro de téléphone: 6262 +31433871956
- E-mail: m.poeze@ah.unimaas.nl
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Contact:
- Nina Wijnands, MD, PhD-student
- Numéro de téléphone: 9115 +3143 3881497
- E-mail: n.wijnands@ah.unimaas.nl
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Chercheur principal:
- Martijn Poeze, MD,PhD
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Sous-enquêteur:
- nina Wijnands, MD, PhD-student
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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normal fracture healing
group in which normal fracture healing has occured
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aucune intervention
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atrophic
patients in which an atrophic non-union occured
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aucune intervention
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hypertrophic
patients in which a hypertrophic non-union occured
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aucune intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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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
Délai: 1 year
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1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Martijn Poeze, MD, PhD, Maastricht University Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MEC-09-2-123
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