Weight Loss Surgery + Knee Replacement for Obesity and Osteoarthritis

(OMEOSKO Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Must not be taking: Anti-coagulation therapy

Disqualifiers: Cardiovascular, Pulmonary, Renal, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether weight loss surgery before knee replacement can improve outcomes for individuals with both obesity and severe knee osteoarthritis. Participants will either receive standard dietary and lifestyle counseling or undergo a sleeve gastrectomy (a type of weight loss surgery) followed by the same counseling before their knee surgery. Ideal candidates have a body-mass index (BMI) between 45 and 60 and suffer from severe knee osteoarthritis. The trial aims to determine the best approach to enhance knee surgery results for those with significant weight issues. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve surgical outcomes for patients facing similar health challenges.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anti-coagulation therapy, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bariatric surgery, such as sleeve gastrectomy, is generally well-tolerated. One study compared sleeve gastrectomy to another type of weight loss surgery and found it safe for up to five years post-procedure. Many patients see significant improvements in obesity-related health issues within six months after surgery.

While side effects can occur, they are usually manageable. The FDA has approved this surgery for treating obesity, indicating a strong safety record when performed by experienced surgeons. Prospective trial participants should discuss potential risks with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining bariatric surgery with knee replacement for obesity and osteoarthritis because it offers a dual approach to treatment. Unlike standard care, which typically involves dietary and lifestyle counseling, this approach includes surgical weight loss through sleeve gastrectomy. This method not only helps in reducing excess weight but could also lead to better outcomes for knee replacement surgery by lessening the strain on the joints and improving overall mobility. By addressing both weight and joint issues, this treatment could enhance recovery and long-term joint health for patients with obesity and osteoarthritis.

What evidence suggests that this trial's treatments could be effective for obesity and osteoarthritis?

Research has shown that weight-loss surgery, such as sleeve gastrectomy, can significantly aid obese patients in losing weight. Studies have found that patients may lose about 22.5% of their total weight within five years post-surgery. This weight loss often proves more effective than lifestyle changes alone. In this trial, some participants will undergo surgical weight loss, including sleeve gastrectomy, combined with dietary and lifestyle counseling before total knee replacement. This approach might reduce stress on the knees, potentially enhancing recovery from knee replacement surgery. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with severe knee osteoarthritis who are extremely obese, having a BMI between 45 to 60. It's designed to see if losing weight before knee surgery can help improve the results of the surgery.

Inclusion Criteria

I have severe knee pain from arthritis and my BMI is between 45 and 60.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary and Lifestyle Counseling

Participants receive dietary and lifestyle counseling for weight management

9-13 months

Surgical Intervention

Participants in the treatment arm undergo sleeve gastrectomy

1-2 weeks

Total Knee Replacement

Participants undergo total knee replacement surgery

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Bariatric Surgery
• Total Knee Replacement

Trial Overview The study is testing whether undergoing bariatric (weight loss) surgery prior to total knee replacement provides better outcomes than just having the knee replacement without prior weight loss surgery.

How Is the Trial Designed?

Group I: Surgical weight loss Experimental Treatment 1 Intervention

sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement

Group II: Standard of Care Active Control 1 Intervention

dietary and lifestyle counseling prior to total knee replacement

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?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

In a study of 5125 participants with type 2 diabetes, those who underwent an intensive lifestyle intervention (ILI) to achieve weight loss showed a 29% reduced risk of total knee replacement (TKR) if they had no knee pain at baseline, compared to those receiving standard diabetes support.

However, for participants who already had knee pain at baseline, the ILI did not significantly reduce the risk of TKR, indicating that weight loss interventions may be more beneficial before the onset of knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of the Intensive Lifestyle Intervention With Total Knee Replacement in the Look AHEAD (Action for Health in Diabetes) Clinical Trial. Richey, PA., Johnson, KC., Neiberg, RH., et al.[2022]

In a study of 7388 patients who underwent conversion from sleeve gastrectomy to either Roux-en-Y gastric bypass (RYGB), single anastomosis duodeno-ileal bypass (SADI), or biliopancreatic diversion with duodenal switch (BPD-DS), all procedures showed similar safety profiles with comparable 30-day complication and mortality rates.

However, patients undergoing SADI and BPD-DS experienced longer operative times and higher rates of leaks, indicating that while the overall safety is similar, these specific procedures may carry additional risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisional Procedures after Sleeve Gastrectomy for Weight Recurrence or Inadequate Weight Loss: An Analysis of the MBSAQIP Database. Hage, K., Barajas-Gamboa, JS., Romero-Velez, G., et al.[2023]

Biliopancreatic bypass with duodenal switch led to significant weight loss in patients, dropping from an average of 153.8 kg to 92.7 kg within one year, indicating its efficacy for treating morbid obesity.

However, the procedure is associated with a high risk of nutritional deficiencies and complications, particularly in patients with common channels shorter than 100 cm, suggesting that this surgery should be performed with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutritional status after surgical treatment of obesity]. Tonstad, S., Sundfør, T., Myrvoll, EA.[2008]

Bariatric surgery significantly improved pain levels and quality of life in morbidly obese patients with knee osteoarthritis, as evidenced by lower Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores six months post-surgery.

Improvements in knee joint space measurements were observed after surgery, but the benefits in pain and functionality were not directly linked to the amount of weight lost, suggesting other factors may contribute to these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of bariatric surgery on knee osteoarthritis, knee pain and quality of life in female patients. Üstün, I., Solmaz, A., Gülçiçek, OB., et al.[2020]

From 2005 to 2014, the number of bariatric surgeries performed on patients with knee osteoarthritis remained stable at around 3,300 annually, despite an increase in patient age and comorbidities like diabetes.

Bariatric surgery for knee osteoarthritis patients is considered safe, with in-hospital mortality rates consistently low at 0.0-0.1%, and costs for certain procedures have decreased over the years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in procedure type, patient characteristics, and outcomes among persons with knee osteoarthritis undergoing bariatric surgery, 2005-2014. Gong, Y., Selzer, F., Deshpande, B., 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]

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]

Biliopancreatic diversion with duodenal switch leads to significant weight loss, achieving 70% to 80% excess weight loss with manageable long-term nutritional complications.

The laparoscopic version of this surgery is particularly beneficial for super obese patients (BMI >50 kg/m²), providing higher mean excess weight loss while minimizing surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic biliopancreatic diversion with duodenal switch. Feng, JJ., Gagner, M.[2004]

Bariatric surgery performed two years before total knee arthroplasty significantly improves quality-adjusted life-years (QALYs) compared to undergoing total knee arthroplasty alone in morbidly obese patients, making it a more effective treatment option.

The cost-effectiveness analysis showed that the incremental cost-effectiveness ratio (ICER) for bariatric surgery prior to knee surgery is approximately $13,910 per QALY, which is well below the commonly accepted threshold of $100,000 per QALY, indicating it is a financially viable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Bariatric Surgery Prior to Total Knee Arthroplasty in the Morbidly Obese: A Computer Model-Based Evaluation. McLawhorn, AS., Southren, D., Wang, YC., et al.[2019]

Both laparoscopic gastric bypass and laparoscopic sleeve gastrectomy effectively reduced BMI and improved diabetic conditions in overweight and obese patients with type-2 diabetes, with significant improvements in various metabolic markers post-surgery.

Laparoscopic sleeve gastrectomy was associated with shorter surgery times and less intraoperative blood loss compared to gastric bypass, making it a potentially safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of laparoscopic gastric bypass vs laparoscopic sleeve gastrectomy in treating obesity combined with type-2 diabetes. Yan, Y., Wang, F., Chen, H., 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]

Roux-en-Y gastric bypass (RYGB) significantly improves quality-adjusted life expectancy by 1.35 years for knee osteoarthritis patients with a BMI ≥40 kg/m2, while also being cost-effective at an incremental cost-effectiveness ratio of $5,300 per quality-adjusted life year (QALY).

Laparoscopic sleeve gastrectomy (LSG) showed less benefit compared to RYGB but may be a good option for patients with a BMI between 35 and 41 kg/m2, as it also reduced opioid use and increased total knee replacement (TKR) rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Surgical Weight-Loss Interventions for Patients With Knee Osteoarthritis and Class III Obesity. Kostic, AM., Leifer, VP., Gong, Y., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10353499/

Long-term effectiveness, outcomes and complications of ... Studies have shown that bariatric surgery leads to more significant weight loss and is more effective in treating type 2 diabetes in obese patients than non- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6320354/

Long-Term Outcomes After Bariatric Surgery: a Systematic ... Eighteen reports of gastric bypass showed a weighted mean of 56.7%EWL, 17 reports of LAGB showed 45.9%EWL, 9 reports of biliopancreatic bypass +/− duodenal ...

3. asmbs.org asmbs.org/news_releases/new-study-shows-long-term-effectiveness-of-gastric-bypass-in-treating-type-2-diabetes-and-obesity/

New Study Shows Long-term Effectiveness of Gastric ... Peak weight loss of 31.8% was achieved after 18 months and stabilized at 23% after 10 years and up to the 20-year mark. The overall 15-year ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2815401

Long-Term Outcomes of Medical Management vs Bariatric ... Weight loss was significantly greater 7 years after bariatric surgery, with 8.3% weight loss (95% CI, 6.1%-10.5%) in the medical/lifestyle group ...

5. thelancet.com thelancet.com/journals/lanepe/article/PIIS2666-7762(24)00002-4/fulltext

Long-term effect of sleeve gastrectomy vs Roux-en-Y ... Total weight loss at 5 years was 22.5% [95% CI, 20.7%–24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%–27.8%] after Roux-en-Y gastric bypass (difference ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8495604/

Comparative Safety of Sleeve Gastrectomy and Gastric ... This cohort study investigates the safety of sleeve gastrectomy vs gastric bypass up to 5 years after surgery in patients with severe obesity.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667008924000090

Long-term outcomes of bariatric surgery: An eight-year ... Excess Weight Loss (%EWL) peaked at 75.09 % by the third year, while Total Weight Loss (%TWL) sustained at 33.41 % after two years. Among individuals with type ...

8. massgeneral.org massgeneral.org/digestive/weight-center/surgical-treatments/weight-loss-surgery-patient-outcomes

Patient Outcomes for Weight Loss Surgery Within six months, many of our laparoscopic sleeve gastrectomy patients have achieved dramatic reductions in obesity-related conditions and have improved their ...