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NCT Number: NCT05120492

Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Body Weight Joint Diseases Morbid Obesity Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Osteoarthritis Osteoarthritis, Knee Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health

Halifax, Nova Scotia, B4E 0H4, Canada

Location status: Recruiting

Location contact

James Ellsmere, MD

CONTACT

[email protected]

902-473-1886

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery followed by total knee replacement

Procedure

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

Primary outcomes

  1. Pain, mobility and quality of Life

    Time frame: 1 year

    Knee Injury and Osteoarthritis Outcome Score (KOOS4)

Secondary outcomes

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

    Time frame: 1 year

    assessing quality of life.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Acronym: OMEOSKO

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 15, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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