A Multicentre Randomised Placebo-Controlled Trail of Ibuprofen for the Prevention of Ectopic Bone-Related Pain and Disability After Elective Hip Replacement Surgery (HIPAID)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 主要终点
- Self-reported pain and physical function (WOMAC)
研究概览
简要总结
The primary aim of this randomised trial is to determine the effects of a short peri-operative course of treatment with a non-steroidal anti-inflammatory drug (NSAID), ibuprofen, on the long-term consequences of ectopic bone formation in patients undergoing elective total hip replacement surgery. The specific hypotheses to be tested at that 6 to 12 months after surgery, patients assigned post-operative ibuprofen will have less self-reported pain and physical disability, greater health-related quality of life and reduced ectopic bone formation compared with those assigned placebo.
详细描述
Methodology:
The study is a multicentre, randomised, double blind, placebo-controlled trial. 1000 patients undergoing elective total hip replacement surgery from 20 orthopaedic centres in Australia and New Zealand will be assigned to receive either ibuprofen (1200mg daily) or matching placebo in 3 divided doses for 14 days. Study treatment will be started postoperatively on the day of surgery. Patient should not receive any other NSAIDs, apart from low dose aspirin, during the 14-day treatment period, unless such treatment becomes definitely indicated, in which case the study treatment should be withdrawn and open label treatment provided. There will be no other changes to standard care.
Participants:
All patient scheduled for elective total hip replacement surgery, or revision thereof, are potentially eligible unless there is a definite indication for or contraindication to treatment with a NSAID during the 14-day treatment period.
Randomisation:
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
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing elective total hip replacement surgery, or revision thereof -
排除标准
- •A definite indication or contra-indication for treatment with a NSAID during the 14-day study treatment period, in the opinion of the treating clinician.
结局指标
主要结局
Self-reported pain and physical function (WOMAC)
次要结局
- Health-related quality of life (SF36v2)
- Patients' global assessment
- Physical performance measures: hip flexion, 50ft walk time, up and go.
- Major bleeding events: bleeding from wound > 3 days, evacuation of wound hematoma, hematemesis, melaena, other.