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

NCT01070576 | Unknown

• 1 other identifier: MEC-09-2-123
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Healing; Atrophic Non Union Development; Hypertrophic Non Union Development

Keywords

non union; fracture; healing; arginine; NO

Outcome Measures

Primary Outcomes (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

  1 year

Study Arms (3)

normal fracture healing

group in which normal fracture healing has occured

Other: no intervention

atrophic

patients in which an atrophic non-union occured

Other: no intervention

hypertrophic

patients in which a hypertrophic non-union occured

Other: no intervention

Interventions

no intervention OTHER

no intervention

atrophic; hypertrophic; normal fracture healing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an acute fracture of the femur or tibia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229ER, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bone debris and bloodsamples for amino acid determination

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Martijn Poeze, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martijn Poeze, MD, PhD

CONTACT

+31433876543; m.poeze@ah.unimaas.nl

Nina Wijnands, MD, PhD-student

CONTACT

+31 43 3881497; n.wijnands@ah.unimaas.nl

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: April 7, 2010

Record last verified: 2010-04

Locations

NL (1)