Weight Loss Surgery + Knee Replacement for Obesity and Osteoarthritis
(OMEOSKO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Scotia Health Authority
Must not be taking: Anti-coagulation therapy
Disqualifiers: Cardiovascular, Pulmonary, Renal, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery
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.
What data supports the effectiveness of the treatment Weight Loss Surgery + Knee Replacement for Obesity and Osteoarthritis?
Research shows that bariatric surgery (weight loss surgery) is effective for severe obesity and can improve symptoms and quality of life in patients with knee osteoarthritis. It leads to sustained weight loss and improvement of related health issues, which can be beneficial for those undergoing knee replacement surgery.
12345Is weight loss surgery generally safe for humans?
Weight loss surgeries like gastric bypass and sleeve gastrectomy are generally considered safe, but they can have risks such as vitamin deficiencies, bleeding, and leaks. These procedures have been studied for safety in treating obesity and related conditions like type-2 diabetes.
678910How is the treatment of bariatric surgery unique for obesity and knee osteoarthritis?
Bariatric surgery is unique because it not only helps with significant weight loss in severely obese patients but also improves symptoms of knee osteoarthritis, potentially enhancing quality of life and making knee replacement surgery more effective and cost-efficient.
12111213Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical weight lossExperimental Treatment1 Intervention
sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement
Group II: Standard of CareActive Control1 Intervention
dietary and lifestyle counseling prior to total knee replacement
Bariatric Surgery is already approved in European Union, United States, Canada, Australia 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
🇦🇺 Approved in Australia 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
Research Locations NearbySelect from list below to view details:
Nova Scotia HealthHalifax, Canada
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Who Is Running the Clinical Trial?
Nova Scotia Health AuthorityLead Sponsor
References
Effects of bariatric surgery on knee osteoarthritis, knee pain and quality of life in female patients. [2020]Bariatric surgery is an effective intervention for severe obesity and associated comorbidities. We compared symptoms, joint space and life quality of morbidly obese patients with symptomatic knee osteoarthritis before and after bariatric surgery.
Trends in procedure type, patient characteristics, and outcomes among persons with knee osteoarthritis undergoing bariatric surgery, 2005-2014. [2019]To evaluate trends in the utilization, clinical characteristics, and inpatient outcomes among persons with knee osteoarthritis undergoing bariatric surgery.
Imaging following bariatric procedures: Roux-en-Y gastric bypass, gastric sleeve, and biliopancreatic diversion. [2016]Morbid obesity remains as a common and increasing health problem. Due to limited long-term success with nonsurgical weight loss measures for morbid obesity, bariatric surgery is being performed more and more often in both academic and private practice settings and has proven to be an effective treatment option with sustained weight loss, decreased morbidity, reversal of comorbidities, and prolonged life expectancies [Am J Clin Nutr 55:615S-619S, 1992; Brolin, Nutrition 12:403-404, 1996; Fisher and Schauer, Am J Surg 184:9S-16S 2002]. The Roux-en-Y gastric bypass, biliopancreatic diversion, and gastric sleeve will be discussed in terms of their expected imaging appearance and potential complications.
Ten-year outcomes of Roux-en-Y gastric bypass are equivalent in patients with Medicare disability and non-Medicare patients. [2019]Bariatric surgery is the most effective intervention for achieving durable weight loss and improvement of comorbidities in patients with obesity. Limited data exist on the impact of Medicare status in patients undergoing Roux-en-Y gastric bypass. We hypothesized that there is no difference in outcomes between Medicare beneficiaries and non-Medicare patients at the 10-year follow-up.
Laparoscopic biliopancreatic diversion with duodenal switch. [2004]The biliopancreatic diversion with duodenal switch combines a sleeve gastrectomy with a duodenoileal switch to achieve maximum weight loss. Consistent excess weight loss between 70% to 80% is achieved with acceptable decreased long-term nutritional complications. With a higher entry weight, the super obese patient (body mass index [BMI] >50 kg/m(2)) benefits the greatest from a procedure that produces a higher mean excess weight loss. The laparoscopic approach to this procedure has successfully created a surgical technique with optimum benefit and minimal morbidity, especially in the super obese patient.
[Nutritional status after surgical treatment of obesity]. [2008]Biliopancreatic bypass with duodenal switch is a treatment for morbid obesity that combines restriction of dietary intake with a high degree of malabsorption. The operation involves the risk of losing important nutritional elements.
Revisional Procedures after Sleeve Gastrectomy for Weight Recurrence or Inadequate Weight Loss: An Analysis of the MBSAQIP Database. [2023]The safety of conversional bariatric procedures after sleeve gastrectomy (SG) for weight recurrence (WR) or inadequate weight loss (IWL) is debated due to limited evidence. Conversion options include Roux-en-Y gastric bypass (RYGB), single anastomosis duodeno-ileal bypass (SADI), and biliopancreatic diversion with duodenal switch (BPD-DS). We aimed to compare serious complications and mortality rates between these procedures within 30 days.
Laparoscopic conversion of Roux-en-Y gastric bypass to sleeve gastrectomy as first step of duodenal switch: technique and preliminary outcomes. [2021]Weight loss issues are one of the problems that can affect patients after undergoing bariatric surgery. We report the feasibility, safety and preliminary outcomes of laparoscopic conversion of Roux-en-Y gastric bypass (RYGB) to sleeve gastrectomy (SG), as a first step of duodenal switch (DS), for insufficient weight loss or weight regain.
Duodenal stump leak following a duodenal switch: A case report. [2020]Duodenal switch (DS) is a superior choice for surgical weight loss in the super obese patient population. However, there is an associated risk of adverse events following a DS procedure including vitamin deficiencies, bleeding, obstruction, stricture, and leakage.
Efficacy of laparoscopic gastric bypass vs laparoscopic sleeve gastrectomy in treating obesity combined with type-2 diabetes. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">This prospective study compared the efficacy and safety of laparoscopic gastric bypass and laparoscopic sleeve gastrectomy in treating overweight and obese patients with BMI>28 kg/m2 and type-2 diabetes.
Cost-Effectiveness of Bariatric Surgery Prior to Total Knee Arthroplasty in the Morbidly Obese: A Computer Model-Based Evaluation. [2019]Obesity is associated with adverse outcomes and increased costs after total knee arthroplasty. Bariatric surgery is an effective treatment for morbid obesity, but its cost-effectiveness for weight loss prior to total knee arthroplasty is unknown. The purpose of this study was to evaluate the cost-effectiveness of bariatric surgery prior to total knee arthroplasty for patients in whom medical treatment of obesity and knee osteoarthritis had failed.
Cost-Effectiveness of Surgical Weight-Loss Interventions for Patients With Knee Osteoarthritis and Class III Obesity. [2023]Label="OBJECTIVE">Class III obesity (body mass index [BMI] ≥40 kg/m2 ) is associated with worse knee pain and total knee replacement (TKR) outcomes. Because bariatric surgery yields sustainable weight loss for individuals with BMI ≥40 kg/m2 , our objective was to establish the value of Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (LSG) in conjunction with usual care for knee osteoarthritis (OA) patients with BMI ≥40 kg/m2 .
Association of the Intensive Lifestyle Intervention With Total Knee Replacement in the Look AHEAD (Action for Health in Diabetes) Clinical Trial. [2022]Evidence has established obesity as a risk factor for total knee replacement (TKR) due to osteoarthritis. Obesity is a risk factor for TKR. Randomized trials such as Look AHEAD (Action for Health in Diabetes) have shown long-term successful weight loss with an intensive lifestyle intervention (ILI). It is unknown, however, if intentional weight loss can reduce the risk of TKR.