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NCT05120492 Clinical Trial

Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

Knee Osteoarthritis Clinical Trial

— OMEOSKO  

Official title:
Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05120492
Other study ID # 41155
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2021
Est. completion date January 2024

Study information
Verified date November 2021
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date January 2024
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 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 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• bariatric surgery followed by total knee replacement
The only intervention is the randomization of the priority of the 2 procedures.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nova Scotia Health Authority

Outcome
Type Measure Description Time frame Safety issue
Primary Pain, mobility and quality of Life Knee Injury and Osteoarthritis Outcome Score (KOOS4) 1 year
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