Optimizing the Body Mass Index: A Randomized Clinical Trial to Assess the Efficacy of Bariatric Surgery vs Medical Weight Loss in Morbidly Obese Patients Prior to Total Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Bariatric surgery to achieve a BMI ≤ 40 kg/m2
研究概览
简要总结
This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs medical weight loss vs. the "usual standard of care" to optimize a morbidly obese patient with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty (TJA).
The study population will include patients with hip or knee joint osteoarthritis and BMI (Body Mass Index) > 40 kg/m2 who are evaluated in the joint arthroplasty clinic at Boston Medical Center.
The primary objective of the study is to determine if bariatric surgery or medical weight loss is more effective than the usual standard of care in optimizing a morbidly obese patient with osteoarthritis of the hip or knee joint for TJA. This will be determined by comparing the number of patients within each group who are able to lose weight through either bariatric surgery, medical weight loss, or the usual standard of care to achieve a BMI ≤ 40 kg/m2 to eventually undergo TJA.
The secondary objectives of this study are to compare total operative time, postoperative complication rates, readmission rates, percentage of total body weight lost, revision rate, and reoperation rate. The ability of patients within each study arm to maintain a BMI ≤ 40 kg/m2 for up to 2 years after undergoing TJA will also be assessed, as well as their level of satisfaction before and after being in the study.
详细描述
In this prospective RCT, eligible participants will be randomized to one of three arms - the bariatric surgery study arm, the medical weight loss study arm, or the "usual standard of care" study arm. Each patient's progress will be monitored during visits by study personnel. Participants will also have telemedicine visits with an arthroplasty physician assistant every 3 months to ensure they are making progress in terms of weight loss and becoming a safer candidate for TJA. Participants will complete research surveys every 3 months during the telemedicine visits to provide feedback regarding their progress and weight loss methods.
After the study participant has achieved a BMI ≤ 40 kg/m2, they will undergo TJA and will be seen postoperatively in the arthroplasty clinic for routine follow up visits. Patients will continue to complete patient research surveys every 3 months via telemedicine for up to 2 years to provide feedback regarding how they are managing with their weight loss after undergoing TJA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient must be 18 years or older who has met the clinical/standard care criteria for TJA (patient must have exhausted conservative measures to treat hip or knee joint arthritis (NSAIDS, physical therapy, corticosteroid injections)), except patient has a BMI > 40 kg/m2
- •Patient must be interested in TJA as a treatment option
- •Patient must be willing to be randomized to either a bariatric surgery study arm, a medical weight loss study arm, or a "usual standard of care" study arm
排除标准
- •Patient has undergone prior laparoscopic sleeve gastrectomy or gastric bypass
- •Patient has undergone prior hip or knee joint replacement for the affected joint
- •Active substance use disorder
- •Females with child-bearing potential
研究组 & 干预措施
Bariatric surgery group
Participants randomized to the bariatric surgery arm will undergo either a laparoscopic sleeve gastrectomy or a laparoscopic gastric bypass to achieve a BMI ≤ 40 kg/m2.
干预措施: Patient research surveys (Other)
Bariatric surgery group
Participants randomized to the bariatric surgery arm will undergo either a laparoscopic sleeve gastrectomy or a laparoscopic gastric bypass to achieve a BMI ≤ 40 kg/m2.
干预措施: Bariatric surgery (Procedure)
Bariatric surgery group
Participants randomized to the bariatric surgery arm will undergo either a laparoscopic sleeve gastrectomy or a laparoscopic gastric bypass to achieve a BMI ≤ 40 kg/m2.
干预措施: Total joint arthroplasty (TJA) (Procedure)
Medical weight loss group
Participants randomized to the medical weight loss study arm will attempt to lose weight through diet, exercise, and potentially pharmacotherapy an effort to lower their BMI to ≤ 40 kg/m2.
干预措施: Medical weight loss (Behavioral)
Medical weight loss group
Participants randomized to the medical weight loss study arm will attempt to lose weight through diet, exercise, and potentially pharmacotherapy an effort to lower their BMI to ≤ 40 kg/m2.
干预措施: Patient research surveys (Other)
Medical weight loss group
Participants randomized to the medical weight loss study arm will attempt to lose weight through diet, exercise, and potentially pharmacotherapy an effort to lower their BMI to ≤ 40 kg/m2.
干预措施: Total joint arthroplasty (TJA) (Procedure)
"Usual Standard of Care"
Patients randomized to the "usual standard of care" study arm will be counseled on the importance of losing weight to optimize their BMI and will be provided with referral information (name and clinic number) to either the bariatric surgery or medical weight loss clinics.
干预措施: Total joint arthroplasty (TJA) (Procedure)
"Usual Standard of Care"
Patients randomized to the "usual standard of care" study arm will be counseled on the importance of losing weight to optimize their BMI and will be provided with referral information (name and clinic number) to either the bariatric surgery or medical weight loss clinics.
干预措施: Usual standard of care (Other)
结局指标
主要结局
Bariatric surgery to achieve a BMI ≤ 40 kg/m2
时间窗: 12 months
The number of patients who are able to achieve a BMI ≤ 40 kg/m2 prior to total joint arthroplasty (TJA) will be analyzed.
Medical weight loss to achieve a BMI ≤ 40 kg/m2
时间窗: 12 months
The number of patients who are able to achieve a BMI ≤ 40 kg/m2 prior to total joint arthroplasty (TJA) will be analyzed.
次要结局
- Surgical site infection rate(90 days after TJA)
- Percentage change in body weight(Baseline, day of TJA)
- Length of hospital stay for TJA procedure(Day of surgery until discharge from hospital, up to 7 days)
- Prosthetic joint infection rate(90 days after TJA)
- Total TJA operative time(Day of surgery)
- Venous thromboembolism rate(90 days after TJA)
- Urinary tract infection rate(90 days after TJA)
- Change in patient satisfaction with weight loss procedure(Baseline, 24 months)
- Hematoma rate(90 days after TJA)
- Cardiac event rate(90 days after TJA)
- 90 day postoperative readmission rate(90 days after TJA)
- 24 month revision rate(24 months)
- 24 month reoperation rate(24 months)
- Maintained a BMI ≤ 40 kg/m2 post TJA(24 months post TJA)