Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- variation of knee joint space thickness
研究概览
简要总结
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
Knee MRI is not currently part of the investigations preceding bariatric surgery.
详细描述
Assessment of knee arthrosis in severely obese patients after bariatric surgery.
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bariatric surgery
- •IMC >= 35
排除标准
- •those of bariatric surgery
- •contra-indication to MRI
- •pregnancy
结局指标
主要结局
variation of knee joint space thickness
时间窗: 24 hours, one year
Joint space variation in percentages (mean joint space variation calculated for each patient group). Mean joint space comparison between 2 groups of obese patients: patients with Bypass surgery versus patients without surgery.
proportion of patients with pain
时间窗: 1 year
proportion of patients with Pain Scores on the Visual Analog Scale ≥ 30/100 (for at least one knee). Comparison at one year after bariatric surgery versus inclusion.
次要结局
- mean pain and disability(24 hours)
- evolution of KOOS score after surgery(6 months, 1 year and two years)
- evolution of pain scores after surgery(6 months, 1 year, 2 years)
- prevalence of atherosis(24 hours)
- evolution of the proportion of patients in pain(6 months, 1 year and two years)
- evolution of knee MRI parameters after surgery(6 months, 1 year and two years)