Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First? a Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- SF-36 Physical Function Component Score
研究概览
简要总结
The goal of this study is to determine whether undergoing bariatric surgery before knee replacement leads to better outcomes compared to undergoing knee replacement before bariatric surgery. Our secondary goal is to compare complication rates between these groups to determine if there is a difference based on the order of the two procedures.
Participants will be randomly placed in one of two groups, with each undergoing both procedures but in opposite order. Quality of life will be assessed via questionnaires before and between each procedure, and rates of complications will also be documented to compare their rates between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •BMI > or = 35, on surgical waitlist for a total knee arthroplasty and laparoscopic sleeve gastrectomy
排除标准
- •a history of revision surgery, surgery for neoplastic disease, significant mental illness, ASA class > 3 denoting absence of significant impact of comorbidities, and previous esophagogastric surgery.
研究组 & 干预措施
Sleeve Gastrectomy then Knee Arthroplasty
Participants in this arm will undergo laparoscopic sleeve gastrectomy followed by a total knee arthroplasty at least 1 year following the first procedure.
干预措施: total knee arthroplasty (Procedure)
Sleeve Gastrectomy then Knee Arthroplasty
Participants in this arm will undergo laparoscopic sleeve gastrectomy followed by a total knee arthroplasty at least 1 year following the first procedure.
干预措施: laparoscopic sleeve gastrectomy (Procedure)
Knee Arthroplasty then Sleeve Gastrectomy
Participants in this arm will undergo total knee arthroplasty followed by laparoscopic sleeve gastrectomy at least 1 year following the first procedure.
干预措施: laparoscopic sleeve gastrectomy (Procedure)
Knee Arthroplasty then Sleeve Gastrectomy
Participants in this arm will undergo total knee arthroplasty followed by laparoscopic sleeve gastrectomy at least 1 year following the first procedure.
干预措施: total knee arthroplasty (Procedure)
结局指标
主要结局
SF-36 Physical Function Component Score
时间窗: At baseline/enrollment followed by a year following each procedure.
The 36-Item Short-Form Survey (SF-36) Physical Function Component Score will be assessed 1 year after each procedure as a measure of quality of life.
次要结局
- SF-36 Mental Component Score(At baseline/enrolment followed by a year after each procedure)
- Knee Osteoarthritis Outcome Score (KOOS)(At baseline/enrolment in addition to a year following each procedure)
- Post-Operative Outcomes(At 12 and 24 months following each intervention)
- Post-Operative Complications(Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.)
研究者
Nick Smith
Dr. Nicholas Smith, Clinical Assistant Professor of Surgery (Orthopaedics)
Memorial University of Newfoundland