Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- There is no difference in ulnohumeral flexion
研究概览
简要总结
Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.
Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.
The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18 years or greater
- •Operative treatment of one of the following injuries
- •An elbow dislocation with or without associated fractures
- •An olecranon fracture-dislocation, but not simple olecranon fractures
- •A distal humerus fracture
排除标准
- •An existing diagnosis of one of the following conditions
- •Injury to the central nervous system, thorax, or abdomen precluding the immediate use of non-steroidal anti-inflammatory medications
- •Fracture of any long bone since non-steroidal anti-inflammatory medications may increase the risk of nonunion
- •History of gastritis, peptic ulcer disease, or upper gastrointestinal bleeding
- •Impaired renal function (creatinine > 2.0), hypovolemia, heart failure, high blood pressure ( > 160/90), fluid retention, asthma, liver dysfunction (bilirubin > 2.0), or a coagulation disorder
- •Allergy to non-steroidal anti-inflammatory medications
- •Asthma, nasal polyps, urticaria, and hypotension associated with the use of NSAIDs
- •Considerable dehydration
- •Pregnant or breast-feeding women
- •Concomitant use of one of the following drugs:
- •Other naproxen products (ec-naprosyn, anaprox, anaprox ds, naprosyn suspension, aleve)
- •Methotrexate
- •Diuretics (thiazides / furosemide)
- •ACE-inhibitors (captopril, enalapril, ramipril etc.)
- •Beta-blockers (propanolol etc.)
- •Probenecid (for gout or hyperuricemia)
- •H2-blockers, sucralfate and intensive antacid therapy
- •Anticoagulants / Warfarin (coumadin, waran, jantoven etc.)
- •Sulfonamides
- •Anticonvulsant medication (peganone, mesantoin, cerebyx, dilantin, etc.)
研究组 & 干预措施
1
Will receive 500 mg Naproxen twice a day for two weeks
干预措施: Naproxen (Drug)
结局指标
主要结局
There is no difference in ulnohumeral flexion
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
David C. Ring, MD
Director of Research, Hand Service
Massachusetts General Hospital