EUCTR2019-004834-40-BE进行中（未招募）1 期
Do peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty? A randomized, single surgeon, placebo controlled, double blind study
niversity Hospitals Leuven0 个研究点目标入组 70 人开始时间: 2020年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- All patients undergoing unilateral uncemented THA for primary OA of AVN of the hip under general anesthesia (GA)
- •- Aged 18 years and above (including women of child bearing age)
- •- Able to provide informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Younger than 18 years
- •- Known alcohol or drug abuse
- •- Known allergy for glucocorticoids
- •- Administration of any glucocorticoids in the last three months
- •- Usage of strong analgesia (such as lyrica, oxycodone) as regular medication
- •- Usage of medication with anticipated interactions with glucocorticoids
- •- Known gastric ulcer
- •- Insulin dependent diabetes mellitus
- •- Severe heart disease (NYHA > 2)
- •- Liver or renal failure
- •- Systemic rheumatoid diseases
- •- Insufficient understanding of the Dutch language
- •- Unable to provide informed consent
- •- Pre-operative use of walking aids
- •- Gross anatomical deformities
- •- Significant intra-operative complication such as peri-prosthetic fracture
研究者
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