Weight Loss Strategies for Osteoarthritis

Overseen By Christopher A Worgul, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Substance use disorder, Prior surgeries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

138 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 10 11 12 13}

Who Is on the Research Team?

David M Freccero, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Medical weight loss group Experimental Treatment 3 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 group Experimental Treatment 3 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 Treatment 2 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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging following bariatric procedures: Roux-en-Y gastric bypass, gastric sleeve, and biliopancreatic diversion. Carucci, LR., Turner, MA.[2016]

Bariatric surgery is currently the most effective and sustainable method for significant weight loss in the US, which is crucial given that about two-thirds of the population is overweight or obese.

In addition to aiding weight loss, bariatric surgery has been successful in reversing severe comorbidities associated with obesity, highlighting its potential health benefits beyond just weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative nursing care of the bariatric surgical patient. Ide, P., Farber, ES., Lautz, D.[2019]

Surgical methods, particularly vertical banded gastroplasty and Roux-Y gastric bypass, are currently the most effective treatments for severe obesity, as nonsurgical methods often fail to achieve significant long-term weight loss.

The success of these surgeries relies more on patient motivation and behavior than on the technical aspects of the procedures, suggesting that psychological support and lifestyle changes are crucial for achieving and maintaining weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of surgical techniques for treating obesity. Kral, JG.[2018]

Duodenal switch (DS) surgery can be effective for weight loss in super obese patients, but it carries significant risks, including complications like duodenal stump blowout, which can lead to severe postoperative issues such as bleeding and abdominal pain.

Early diagnosis and appropriate management of duodenal stump leaks are crucial, involving stabilization of the patient and surgical repair, to prevent serious complications following the DS procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duodenal stump leak following a duodenal switch: A case report. Nelson, L., Moon, RC., Teixeira, AF., et al.[2020]

Biliopancreatic diversion with duodenal switch (BPD/DS) leads to significant long-term weight loss, with an average excess BMI loss of around 78% maintained over 14 years, and a high remission rate of type 2 diabetes in 92.8% of patients.

Despite its effectiveness, BPD/DS is associated with notable long-term side effects, including a 29.3% reoperation rate due to complications like malnutrition and insufficient weight loss, highlighting the need for regular follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome after biliopancreatic diversion with duodenal switch: a single-center experience with up to 20 years follow-up. Süsstrunk, J., Schneider, R., Peterli, R., et al.[2023]

In a study of 3,378 primary and 487 revisional biliopancreatic diversion/duodenal switch (BPD/DS) patients, revisional procedures were found to have a higher rate of major complications compared to primary procedures, indicating a safety concern for revisional surgeries.

Despite the higher complexity and longer operative times for revisional BPD/DS, both types of surgeries showed similar rates of 30-day readmissions, reoperations, and mortality, suggesting that while revisional surgeries carry more risk, they do not necessarily lead to worse short-term outcomes in terms of these specific metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Primary Versus Revisional Biliopancreatic Diversion with Duodenal Switch in Patients with Super Obesity Using the MBSAQIP database. Wang, A., Wang, H., Abdurakhmanov, A., et al.[2022]

Laparoscopic conversion from Roux-en-Y gastric bypass (RYGB) to sleeve gastrectomy (SG) is a feasible and safe procedure for patients experiencing insufficient weight loss or weight regain, with no conversions to open surgery and no mortality reported among the four patients studied.

After an average follow-up of 11 months, patients showed significant weight loss improvements, with a mean weight reduction of 20.7 kg and a % excess weight loss of 59.3%, indicating that this conversion can effectively enhance weight loss outcomes before proceeding to the next step of duodenal switch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic conversion of Roux-en-Y gastric bypass to sleeve gastrectomy as first step of duodenal switch: technique and preliminary outcomes. Dapri, G., Cadière, GB., Himpens, J.[2021]

Bariatric surgery is the most effective long-term solution for significant weight loss and improving obesity-related health issues, with benefits including enhanced quality of life and reduced mortality rates.

The mechanisms of action for bariatric surgery include restricting food intake, causing malabsorption, increasing metabolic rate, and altering hunger and satiety hormones, making it a multifaceted approach to weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current State of Bariatric Surgery: Procedures, Data, and Patient Management. Rogers, AM.[2020]

Both Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG) resulted in significant weight loss after one year, with RYGBP patients losing an average of 48.6% of their excess weight and SG patients losing 57.6%.

Despite the weight loss, a high prevalence of vitamin deficiencies was observed post-surgery, with 65% of patients still deficient in vitamin D after one year, and significant decreases in oral hydration were noted, particularly in RYGBP patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Hydration, Food Intake, and Nutritional Status Before and After Bariatric Surgery. Vinolas, H., Barnetche, T., Ferrandi, G., et al.[2020]

Bariatric surgery is more effective for weight loss than lifestyle changes or medications alone, with expected weight loss ranging from 37% to 79% of excess weight within 2 years, depending on the type of surgery performed.

Candidates for surgery typically have a body mass index (BMI) of 40 or higher, or a BMI of 35 with obesity-related health issues, and must commit to lifelong dietary monitoring to prevent nutritional deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity: surgical management. Vesely, JM., DeMattia, LG.[2019]

Combining bariatric surgery with orthopedic interventions, like joint arthroplasty, is shown to be beneficial for patients with severe obesity and osteoarthritis, providing a safe and effective treatment pathway.

This two-step approach not only facilitates successful joint surgery but also encourages lifestyle changes that help patients maintain their weight loss after the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity Disease Pandemic on Joint Disease and Longevity. Milla, C., Lo Menzo, E., Morton, J., et al.[2020]

Citations

1. Brazil pubmed.ncbi.nlm.nih.gov

Revisional surgery in severe nutritional complications after bariatric surgical procedures: report of four cases from a single institution and review of the literature. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Ten-year outcomes of Roux-en-Y gastric bypass are equivalent in patients with Medicare disability and non-Medicare patients. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Imaging following bariatric procedures: Roux-en-Y gastric bypass, gastric sleeve, and biliopancreatic diversion. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative nursing care of the bariatric surgical patient. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Overview of surgical techniques for treating obesity. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Duodenal stump leak following a duodenal switch: A case report. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome after biliopancreatic diversion with duodenal switch: a single-center experience with up to 20 years follow-up. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Primary Versus Revisional Biliopancreatic Diversion with Duodenal Switch in Patients with Super Obesity Using the MBSAQIP database. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic conversion of Roux-en-Y gastric bypass to sleeve gastrectomy as first step of duodenal switch: technique and preliminary outcomes. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Current State of Bariatric Surgery: Procedures, Data, and Patient Management. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Oral Hydration, Food Intake, and Nutritional Status Before and After Bariatric Surgery. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Obesity: surgical management. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Obesity Disease Pandemic on Joint Disease and Longevity. [2020]