Fracture Healing Clinical Trial
Official title:
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.
n/a
Time Perspective: Prospective
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