Fracture HealingNCT01070576
Arginine and Nitric Oxide (NO) Early Prognostic Markers for Non-union Development
An observational study of Fracture Healing and Atrophic Non Union Development, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Healing, Atrophic Non Union Development, Hypertrophic Non Union Development
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an acute fracture of the femur or tibia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, 6229ER
Martijn Poeze, MD, PhD, +31433871956 ext. 6262, m.poeze@ah.unimaas.nl
Nina Wijnands, MD, PhD-student, +3143 3881497 ext. 9115, n.wijnands@ah.unimaas.nl
About this study
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.
Read more
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.
- Being tested
- no intervention
- Keywords
- non union, fracture, healing, arginine, NO
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| normal fracture healing | group in which normal fracture healing has occured Receives: Other: no intervention | |
| atrophic | patients in which an atrophic non-union occured Receives: Other: no intervention | |
| hypertrophic | patients in which a hypertrophic non-union occured Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture HealingStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Martijn Poeze, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070576
- Sponsor's protocol ID
- MEC-09-2-123
- Status last verified
- Apr 2010
- First submitted
- 17 Feb 2010
- Last updated
- 7 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine and Nitric Oxide (NO) Metabolism During Bone Healing and Non-union Development- Early Prognostic Markers
- ClinicalTrials.gov ID
- NCT01070576
- Acronym / sponsor ID
- MEC-09-2-123
- Keywords
- non union, fracture, healing, arginine, NO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (estimated)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal fracture healing | – | Other: no interventiongroup in which normal fracture healing has occured |
| atrophic | – | Other: no interventionpatients in which an atrophic non-union occured |
| hypertrophic | – | Other: no interventionpatients in which a hypertrophic non-union occured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an acute fracture of the femur or tibia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | atrophic, hypertrophic, normal fracture healing |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn Poeze, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture Healing and Atrophic Non Union Development, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martijn Poeze, MD, PhD (+31433876543 ext. 6262, m.poeze@ah.unimaas.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2010.