Arginine and Nitric Oxide (NO) Early Prognostic Markers for Non-union Development
NCT ID: NCT01070576
Last Updated: 2010-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2010-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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normal fracture healing
group in which normal fracture healing has occured
no intervention
no intervention
atrophic
patients in which an atrophic non-union occured
no intervention
no intervention
hypertrophic
patients in which a hypertrophic non-union occured
no intervention
no intervention
Interventions
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no intervention
no intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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MUMC+
Principal Investigators
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Martijn Poeze, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MEC-09-2-123
Identifier Type: -
Identifier Source: org_study_id
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