Weight Loss Strategies for Osteoarthritis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for weight loss in osteoarthritis patients?
Bariatric surgery, including procedures like Roux-en-Y gastric bypass and biliopancreatic diversion, is shown to be the most effective method for achieving long-term weight loss and improving related health conditions in obese individuals. This sustained weight loss can potentially alleviate symptoms of osteoarthritis by reducing the stress on joints.12345
Is weight loss surgery generally safe for humans?
Weight loss surgeries like Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch can lead to long-term weight loss but may have risks such as nutritional deficiencies, bleeding, and other complications. These procedures are generally safe but come with potential side effects that should be considered.16789
How is the treatment for weight loss in osteoarthritis unique?
Bariatric surgery is unique because it is the only treatment that leads to long-term and sustained weight loss by restricting food intake and reducing nutrient absorption, which is not achieved by other weight loss methods. It also offers a bridge to successful joint surgeries for osteoarthritis patients, helping them maintain weight loss and improve their quality of life.110111213
What is the purpose of this trial?
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.
Research Team
David M Freccero, MD
Principal Investigator
Boston Medical Center
Eligibility Criteria
This trial is for adults with severe hip or knee osteoarthritis and obesity (BMI > 40 kg/m2) who have tried other treatments without success. They must be considering total joint replacement surgery but haven't had previous replacements in the affected joints, no active substance use disorders, and not be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either bariatric surgery, medical weight loss, or usual standard of care to achieve a BMI ≤ 40 kg/m2
Surgery
Participants undergo total joint arthroplasty (TJA) after achieving a BMI ≤ 40 kg/m2
Follow-up
Participants are monitored for safety and effectiveness after TJA, including maintaining a BMI ≤ 40 kg/m2
Treatment Details
Interventions
- Bariatric Surgery
- Medical Weight Loss
- Total Joint Arthroplasty (TJA)
Bariatric Surgery is already approved in European Union, United States, Canada for the following indications:
- Severe obesity (BMI ≥35 kg/m2) with comorbidities
- Type 2 diabetes
- Hypertension
- Sleep apnea
- High-risk cardiovascular disease
- Severe obesity (BMI ≥35 kg/m2) with comorbidities
- Type 2 diabetes
- Hypertension
- Sleep apnea
- High-risk cardiovascular disease
- Severe obesity (BMI ≥35 kg/m2) with comorbidities
- Type 2 diabetes
- Hypertension
- Sleep apnea
- High-risk cardiovascular disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Medical Center
Lead Sponsor