Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial (OMEOSKO)

Nova Scotia Health Authority (NSHA)

Status

Enrolling

Conditions

Morbid Obesity

Knee Osteoarthritis

Treatments

Procedure: bariatric surgery followed by total knee replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT05120492

41155

Details and patient eligibility

About

Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

Full description

RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

severe knee osteoarthritis body-mass index of 45 to 60

Exclusion criteria

previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.