138 Participants Needed

Weight Loss Strategies for Osteoarthritis

DM
CA
Overseen ByChristopher A Worgul, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

DM

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

I am over 18, have severe hip or knee arthritis, tried all other treatments, and my BMI is over 40.
I am open to being assigned to any type of weight loss treatment group in the study.
I am considering total joint replacement surgery.

Exclusion Criteria

I am a woman who can become pregnant.
I have had weight loss surgery in the past.
I have had a hip or knee replacement surgery.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either bariatric surgery, medical weight loss, or usual standard of care to achieve a BMI ≤ 40 kg/m2

12 months
Telemedicine visits every 3 months

Surgery

Participants undergo total joint arthroplasty (TJA) after achieving a BMI ≤ 40 kg/m2

Day of surgery

Follow-up

Participants are monitored for safety and effectiveness after TJA, including maintaining a BMI ≤ 40 kg/m2

24 months
Routine follow-up visits and telemedicine every 3 months

Treatment Details

Interventions

  • Bariatric Surgery
  • Medical Weight Loss
  • Total Joint Arthroplasty (TJA)
Trial Overview The study compares three approaches to help morbidly obese patients prepare for joint replacement surgery: bariatric surgery, medical weight loss programs, and usual care. It aims to see which method is best at reducing BMI to ≤ 40 kg/m2 before surgery.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Medical weight loss groupExperimental Treatment3 Interventions
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.
Group II: Bariatric surgery groupExperimental Treatment3 Interventions
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.
Group III: "Usual Standard of Care"Experimental Treatment2 Interventions
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.

Bariatric Surgery is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Bariatric Surgery for:
  • Severe obesity (BMI ≥35 kg/m2) with comorbidities
  • Type 2 diabetes
  • Hypertension
  • Sleep apnea
  • High-risk cardiovascular disease
🇺🇸
Approved in United States as Bariatric Surgery for:
  • Severe obesity (BMI ≥35 kg/m2) with comorbidities
  • Type 2 diabetes
  • Hypertension
  • Sleep apnea
  • High-risk cardiovascular disease
🇨🇦
Approved in Canada as Bariatric Surgery for:
  • 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

Trials
410
Recruited
890,000+

Findings from Research

Bariatric surgery, such as Roux-en-Y gastric bypass and biliopancreatic diversion, is effective for long-term weight loss and reducing health risks in morbidly obese individuals, but it can lead to serious nutritional complications that may require revisional surgery.
In a study of four patients who underwent revisional surgery due to complications, one patient died, highlighting that while revision surgery is rare, it carries increased risks and can involve different surgical approaches depending on the patient's condition.
Revisional surgery in severe nutritional complications after bariatric surgical procedures: report of four cases from a single institution and review of the literature.Braga, JGR., Concon, MM., Lima, AP., et al.[2021]
In a study of 617 patients who underwent Roux-en-Y gastric bypass, Medicare beneficiaries experienced similar long-term weight loss and comorbidity resolution as non-Medicare patients after 10 years, indicating the procedure's effectiveness across different insurance statuses.
Despite Medicare patients being older and having a higher preoperative body mass index, their outcomes were equivalent to those of non-Medicare patients, supporting the case for continued Medicare coverage of bariatric surgery.
Ten-year outcomes of Roux-en-Y gastric bypass are equivalent in patients with Medicare disability and non-Medicare patients.Michaels, AD., Mehaffey, JH., Hawkins, RB., et al.[2019]
Bariatric surgery is increasingly recognized as an effective treatment for morbid obesity, leading to sustained weight loss and improved health outcomes, including decreased morbidity and reversal of related health conditions.
The abstract highlights specific surgical procedures like Roux-en-Y gastric bypass, biliopancreatic diversion, and gastric sleeve, which are associated with distinct imaging appearances and potential complications, emphasizing the need for careful monitoring post-surgery.
Imaging following bariatric procedures: Roux-en-Y gastric bypass, gastric sleeve, and biliopancreatic diversion.Carucci, LR., Turner, MA.[2016]

References

Revisional surgery in severe nutritional complications after bariatric surgical procedures: report of four cases from a single institution and review of the literature. [2021]
Ten-year outcomes of Roux-en-Y gastric bypass are equivalent in patients with Medicare disability and non-Medicare patients. [2019]
Imaging following bariatric procedures: Roux-en-Y gastric bypass, gastric sleeve, and biliopancreatic diversion. [2016]
Perioperative nursing care of the bariatric surgical patient. [2019]
Overview of surgical techniques for treating obesity. [2018]
Duodenal stump leak following a duodenal switch: A case report. [2020]
Long-term outcome after biliopancreatic diversion with duodenal switch: a single-center experience with up to 20 years follow-up. [2023]
Safety of Primary Versus Revisional Biliopancreatic Diversion with Duodenal Switch in Patients with Super Obesity Using the MBSAQIP database. [2022]
Laparoscopic conversion of Roux-en-Y gastric bypass to sleeve gastrectomy as first step of duodenal switch: technique and preliminary outcomes. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Current State of Bariatric Surgery: Procedures, Data, and Patient Management. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Oral Hydration, Food Intake, and Nutritional Status Before and After Bariatric Surgery. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Obesity: surgical management. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Obesity Disease Pandemic on Joint Disease and Longevity. [2020]
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