Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Evaluation of changes of fractures position by X rays investigation
研究概览
简要总结
It is believed, that Non Steroidal Antiinflammatory Drug (NSAID) drugs slows bone healing, but the knowledge is based only on animal studies, and the results are automatically raised for the people.
Many patients with bone fracture must therefore avoid the formerly so popular and good painkillers, although no clinical trial evidence is, that this medicine is really harmful for patients with fractures.
The purpose of this study is to investigate whether these drugs slows bone healing, and what the relationship is between various bone studies - DEXA scanning, biochemical bone marker tests, radiographic controls and tissue examination of newly formed bone under a microscope. How sensitive and specific, each of the above study methods? If they are just as sensitive, the cheapest of them recommended as a routine investigation on suspicion of bone effects. Furthermore, to compare the benefit (pain-relieving effect, influence on rehabilitation) of these drugs and their possible harmful side effects (affected and delayed bone healing).
The expectation is that the study may contribute to increased knowledge about NSAIDs effect do pain management, rehabilitation and the entire treatment process significantly easier and safer, so that patients recover faster and return to usual activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written acceptance to participate in the study
- •immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation).
排除标准
- •age - younger than 50 years or older than 80 years
- •treatment with prednisolon
- •NSAIDs - treatment
- •previous fracture or surgery at the wrist
- •lack of mental and physical capacity to follow studies' instructions
- •lack of informed consent
- •other diseases can affect bone substance (oncology, endocrine diseases)
- •medical contraindications to NSAIDs use
- •smoking, alcohol consumption of more than 14 drinks per week
- •secondary dislocation of fracture also apply as exclusion criterion.
研究组 & 干预措施
NSAIDs in 3 days
NSAIDs (Ibuprofen) in the first 3 days and placebo in the last 4 days
干预措施: Ibuprofen (Drug)
Placebo
Only placebo in 7 days
干预措施: Placebo (Drug)
NSAIDs in 7 days
NSAIDs (Ibuprofen) in 7 days
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Evaluation of changes of fractures position by X rays investigation
时间窗: 1 week, 2 weeks, 6 weeks
Measurement of possible secondary dislocation
次要结局
- Bone Biochemical markers(1 week, 2 weeks, 5 weeks, 3 months, 1 year)
- Histomorfometrical evaluation of bone biopsy from callus area(6 weeks)
- DEXA - scanning(12 weeks)
研究者
Marius Aliuskevicius
Principal Investigator
Aalborg University Hospital