Risk of Revision and Other Complications Following Knee Arthroplasty in Patients Previously Exposed to Bariatric Surgeries: A Nationwide, Register-based Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90,000
- 试验地点
- 1
- 主要终点
- Hazard rate of Revision due to any cause
研究概览
简要总结
Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients.
The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA.
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
- •Primary knee arthroplasty due to osteoarthritis
排除标准
- •Primary knee arthroplasty due to traumatic osteoarthritis.
结局指标
主要结局
Hazard rate of Revision due to any cause
时间窗: within 90 days and within 2 years
Revision surgery is defined as surgery with debridement and/or exchange of at least one component
Hazard rate of Revision due to infection
时间窗: within 90 days and within 2 years
Our definition of infection is adapted from the European Bone and Joint Infection Society (EBJIS) criteria as at least one of the following A. An indication of deep infection is reported to the Danish knee arthroplasty register (DKR) by the surgeon on revision surgery B. At least 2 deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples C. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated.
次要结局
- Mortality(2 years postoperatively)
- Hazard rate of Knee related antibiotic use within 30- and 90-days following KA(within 30- and 90-days following KA)
- Hazard rate of Antibiotic use due to other causes(within 30- and 90-days following KA)
研究者
Saber Muthanna Saber
Principal Investigator, PhD Fellow
Bispebjerg Hospital