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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01070576
First received: February 17, 2010
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

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 Intervention
Fracture Healing
Atrophic Non Union Development
Hypertrophic Non Union Development
Other: no intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Arginine and Nitric Oxide (NO) Metabolism During Bone Healing and Non-union Development- Early Prognostic Markers

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

bone debris and bloodsamples for amino acid determination


Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070576

Contacts
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
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
Principal Investigator: Martijn Poeze, MD, PhD MUMC+
  More Information

No publications provided

Responsible Party: Martijn Poeze, MUMC+
ClinicalTrials.gov Identifier: NCT01070576     History of Changes
Other Study ID Numbers: MEC-09-2-123
Study First Received: February 17, 2010
Last Updated: April 6, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
non union
fracture
healing
arginine
NO

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014