Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial (OMEOSKO)

August 19, 2024 updated by: Nova Scotia Health Authority
Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B4E 0H4
        • Recruiting
        • Nova Scotia Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical weight loss
sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement
Procedure: bariatric surgery followed by total knee replacement
The only intervention is the randomization of the priority of the 2 procedures.
No Intervention: Standard of Care
dietary and lifestyle counseling prior to total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain, mobility and quality of Life
Time Frame: 1 year
Knee Injury and Osteoarthritis Outcome Score (KOOS4)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)
Time Frame: 1 year
assessing quality of life.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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