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Arginine and Nitric Oxide (NO) Early Prognostic Markers for Non-union Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01070576
Recruitment Status : Unknown
Verified April 2010 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : February 18, 2010
Last Update Posted : April 7, 2010
Sponsor:
Information provided by:
Maastricht University Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment
Fracture Healing Atrophic Non Union Development Hypertrophic Non Union Development Other: no intervention

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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Arginine and Nitric Oxide (NO) Metabolism During Bone Healing and Non-union Development- Early Prognostic Markers
Study Start Date : March 2010
Estimated Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
Drug Information available for: Arginine

Group/Cohort Intervention/treatment
normal fracture healing
group in which normal fracture healing has occured
Other: no intervention
no intervention

atrophic
patients in which an atrophic non-union occured
Other: no intervention
no intervention

hypertrophic
patients in which a hypertrophic non-union occured
Other: no intervention
no intervention




Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
bone debris and bloodsamples for amino acid determination


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an acute fracture of the femur or tibia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070576


Contacts
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Contact: Martijn Poeze, MD, PhD +31433876543 ext 6262 m.poeze@ah.unimaas.nl
Contact: Nina Wijnands, MD, PhD-student +31 43 3881497 ext 9115 n.wijnands@ah.unimaas.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229ER
Contact: Martijn Poeze, MD, PhD    +31433871956 ext 6262    m.poeze@ah.unimaas.nl   
Contact: Nina Wijnands, MD, PhD-student    +3143 3881497 ext 9115    n.wijnands@ah.unimaas.nl   
Principal Investigator: Martijn Poeze, MD,PhD         
Sub-Investigator: nina Wijnands, MD, PhD-student         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Martijn Poeze, MD, PhD Maastricht University Medical Center
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Responsible Party: Martijn Poeze, MUMC+
ClinicalTrials.gov Identifier: NCT01070576    
Other Study ID Numbers: MEC-09-2-123
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: April 7, 2010
Last Verified: April 2010
Keywords provided by Maastricht University Medical Center:
non union
fracture
healing
arginine
NO
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical