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Procedure
Weight Loss Surgery + Knee Replacement for Obesity and Osteoarthritis (OMEOSKO Trial)
N/A
Recruiting
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
severe knee osteoarthritis body-mass index of 45 to 60
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates whether weight loss surgery in patients with severe obesity before knee replacement surgery can lead to better outcomes after knee replacement surgery.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical risks associated with surgeries such as infection, bleeding, blood clots, and anesthesia complications. Bariatric surgery also carries specific risks like malnutrition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain, mobility and quality of Life
Secondary study objectives
EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,542 Total Patients Enrolled
11 Trials studying Osteoarthritis
617 Patients Enrolled for Osteoarthritis
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