Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

N/ARecruitingNCT05120492

Nova Scotia Health Authority20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis Morbid Obesity

Interventions

bariatric surgery followed by total knee replacementPROCEDURE

The only intervention is the randomization of the priority of the 2 procedures.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nova Scotia Health

Halifax, Nova Scotia, Canada

RECRUITING

Outcomes

Primary Outcomes

Pain, mobility and quality of Life

Knee Injury and Osteoarthritis Outcome Score (KOOS4)

Time frame: 1 year

Secondary Outcomes

EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)

assessing quality of life.

Time frame: 1 year

Data from ClinicalTrials.gov

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