Knee Osteoarthritis, Morbid Obesity
Conditions
Keywords
Arthroplasty, Replacement, Knee, Bariatric Surgery
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).
Interventions
PROCEDUREbariatric surgery followed by total knee replacement
The only intervention is the randomization of the priority of the 2 procedures.
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, mobility and quality of Life | 1 year | Knee Injury and Osteoarthritis Outcome Score (KOOS4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D) | 1 year | assessing quality of life. |
Countries
Canada
Outcome results
None listed