Safety Aspects of High-Dose Methylprednisolone in Fast-track Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- prosthesis related infections within 1 year after TKA
研究概览
简要总结
It has been shown that a single high dose of steroid before surgery may reduce pain the first 48 hours after insertion of a new joint in the knee, a so called "total knee arthroplasty" (TKA). Consequently, this has been introduced as standard treatment of most patients at several Danish orthopedic departments. Although there are some concerns about the possibility of increased risk of prosthesis infections, this has not been proved in previous studies. However the studies are few, have limited number of patients and are not done using a standardized perioperative set-up.
This study is made to monitor the safety of a single high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery.
We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
详细描述
In order to reduce pain intensity as much as possible after surgical procedures, modern multimodal analgesic strategies using different analgetics targeting different mechanism of the pain reception system are used. At the same time this may reduce the use of opioids, which commonly cause sideeffects such as nausea, vomiting, obstipation,urinary retention, itching, respiratory suppression and sedation.
In spite of the use of a wide perioperative multimodal analgesia, pain after total knee arthroplasty (TKA), is stil a considerable clinical problem and need for optimisation of the immediate postoperative pain treatment. There is evidence that "high"dose glucocorticoids administered preoperatively reduces the level of pain and the use of opioids after surgery. A recent review did not give cause for concern regarding use of glucocorticoids in TKA,but found that data on longterm safety aspects are lacking, why no recommendations could be made.
As the limited evidence presently points to af benefit of glucocorticoids without serious side effects, the treatment has been introduced as standard treatment in TKA at several of the departments participating in the Lundbeck Foundation Centre for fast-track Hip and Knee Replacement collaboration.
This study is made to monitor the safety of high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery.
We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients scheduled for primary unilateral elective TKA and no contraindications for high-dose Methylprednisolone preoperatively
- •Danish Social security number
排除标准
- •One of the following contraindications for Methylprednisolone:
- •Allergy against Methylprednisolone.
- •Currently in systemic treatment with glucocorticoid
- •Current gastric ulcer
- •Insulin dependent diabetes mellitus
- •Further contraindications are at the discretion of the individual department/surgeon. The cohort without preoperative Methylprednisolone treatment will be followed as a separate cohort to identify potential selection bias.
- •Citizens without Danish social security number are not eligible for this study as follow-up is not possible.
结局指标
主要结局
prosthesis related infections within 1 year after TKA
时间窗: 1 year
Causes if infection are subdivided into the following: 1. Deep prosthesis related infection 2. Superficial infection (defined as surgery verified infection above level of the fascia) 3. Clinical / paraclinical suspicion of infection only treated with intravenous antibiotics (no surgical procedure) 4. Possible infection, but no clinical/paraclinical suspicion of infection, why the patient is discharged without intravenous antibiotic treatment/surgery. 5. Surgical wound revision (no clinical/paraclinical suspicion of infection) 6. Surgical knee manipulation due to limited range of movement (no clinical/paraclinical suspicion of infection). 7. Surgery due to aseptic non-traumatic loosening of the knee. 8. Surgery due to traumatic loosening of the knee
次要结局
- Frequency and cause of hospital stay >4 days(primary admission)
- Frequencies and causes of readmissions to orthopedic departments 12 months after TKA.(1 year)
- Frequency and causes of 90 days readmissions(90 days after surgery)
- mortality(90 days and 1 year)
研究者
Christoffer Joergensen
MD
Rigshospitalet, Denmark