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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Steps
研究概览
简要总结
This randomized, single surgeon, placebo controlled, double blind study will be conducted in order to investigate whether or not peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty. So far, it has been proven that high dose glucocorticoids reduce immediate post-operative pain and nausea, but no data exists on functional outcome during the first 6 weeks. Our hypothesis is that patients in the intervention group will follow a so-called "get ahead, stay ahead" principle and that glucocorticoids can be considered an important tool (adjuvant treatment) in the enhanced recovery pathway after THA with significant socio-economic implications.
详细描述
Patients listed for a direct anterior total hip arthroplasty by a single surgeon will be recruited for this study and allocated to one of two groups:
- intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later
- control group: 5 grams of iv dexamethasone at induction followed by placebo 12 hours later Both patients and surgeons will be blinded. Primary outcome measure will be number of steps during the first 6 weeks as measured by a pedometer. Secondary outcome measures will be side effects, complications, Patient Reported Outcome Measures, pain, nausea, stiffness, achievement of clinical milestones and use of analgesia/anti-emetics. This data will be collected using a tailor made application for a smartphone or tablet and data collecting will start one week before surgery until 6 weeks after surgery.
Based on a power analysis both groups will consist of 35 patients each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
An anesthetist or study nurse not involved in further care of the patient nor in the study will prepare the medication to administered based on the allocated group. The first syringe with either 5 or 25 mg of Aacidexam will be administered during induction. The second syringe will go with the patient to the ward and will be administered 12 hours after the surgery by the (blinded) ward nurse. The patient will not be made aware of what has been administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing unilateral uncemented THA for primary OA or AVN of the hip under general anesthesia (GA)
- •Aged 18 years and above (including women of child bearing age)
- •Able to provide informed consent
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 or 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 complications such as periprosthetic fracture
研究组 & 干预措施
Current protocol
"Current protocol": patients will receive a single shot of 25mg of aacidexam iv (5cc) at induction. After 12 hours these patients will another shot of 10mg of aacidexam iv (2cc) on the ward.
干预措施: High dose of peri-operative intravenous dexamethasone (Drug)
Old protocol
"Old protocol": patients will receive a single shot of 5mg of aacidexam iv at induction (5cc). After arrival 12 hours these patients will receive a placebo, i.e. a shot of 2 cc of NaCl 0.9% iv (Mini-Plasco van B. Braun).
干预措施: Low dose of peri-operative intravenous dexamethasone (Drug)
结局指标
主要结局
Steps
时间窗: 6 weeks
Number of steps as measured by a pedometer
次要结局
- Post-operative nausea and vomiting(up to 1 week, 0-10, lower scores indicate better clinical outcome)
- Same day mobilization(1 day (yes or no))
- Clinical milestones(6 weeks)
- Oxford Hip Score(6 weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index(6 weeks)
- Hip dysfunction and Osteoarthritis Outcome Score(6 weeks)
- Forgotten Joint Score(6 weeks)
- Short Form 36(6 weeks)
- Fatigue Severity Scale(6 weeks)
- Groningen Activity Restriction Scale(6 weeks)
- Pain scores(6 weeks, 0-10, lower scores indicate better clinical outcome)
- Stiffness(6 weeks, 0-10, lower scores indicate better clinical outcome)
- Use of Analgesia(6 weeks)
- Use of Anti-emetics(Up to 1 week)
- Complications(6 weeks)
- Side effects(6 weeks)