An observational study in Fracture Healing, Atrophic Non Union Development and Hypertrophic Non Union Development, sponsored by Maastricht University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-07.
Sponsored by Maastricht University Medical Center · Observational
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.
656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 169 observational studies indexed under Hypertrophy.
Browse Hypertrophy studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with an acute fracture of the femur or tibia
Exclusion Criteria:
group in which normal fracture healing has occured
Other: no intervention
patients in which an atrophic non-union occured
Other: no intervention
patients in which a hypertrophic non-union occured
Other: no intervention
no intervention
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
Time frame: 1 year
This study is status unknown, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center