Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain, mobility and quality of Life
研究概览
简要总结
Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery
详细描述
RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •severe knee osteoarthritis body-mass index of 45 to 60
排除标准
- •previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.
研究组 & 干预措施
Surgical weight loss
sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement
干预措施: bariatric surgery followed by total knee replacement (Procedure)
Standard of Care
dietary and lifestyle counseling prior to total knee replacement
结局指标
主要结局
Pain, mobility and quality of Life
时间窗: 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS4)
次要结局
- EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)(1 year)