Arginine and Nitric Oxide (NO) Early Prognostic Markers for Non-union Development
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Maastricht、荷兰、6229ER
- 招聘中
- Maastricht University Medical Center
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接触：
- Martijn Poeze, MD, PhD
- 电话号码：6262 +31433871956
- 邮箱：m.poeze@ah.unimaas.nl
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接触：
- Nina Wijnands, MD, PhD-student
- 电话号码：9115 +3143 3881497
- 邮箱：n.wijnands@ah.unimaas.nl
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首席研究员：
- Martijn Poeze, MD,PhD
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副研究员：
- nina Wijnands, MD, PhD-student
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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normal fracture healing
group in which normal fracture healing has occured
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没有干预
|
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atrophic
patients in which an atrophic non-union occured
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没有干预
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hypertrophic
patients in which a hypertrophic non-union occured
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没有干预
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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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
大体时间：1 year
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1 year
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合作者和调查者
调查人员
- 首席研究员：Martijn Poeze, MD, PhD、Maastricht University Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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