Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis; Morbid Obesity
• Interventions: Procedure: bariatric surgery followed by total knee replacement

• Registration Number: NCT05120492
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Study Start: 2022-04-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical weight loss	bariatric surgery followed by total knee replacement	sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement

Primary Outcome Measures

Name	Time	Method
Pain, mobility and quality of Life	1 year	Knee Injury and Osteoarthritis Outcome Score (KOOS4)

Secondary Outcome Measures

Name	Time	Method
EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)	1 year	assessing quality of life.

Trial Locations

Locations (1)

Nova Scotia Health; 🇨🇦 Halifax, Nova Scotia, Canada