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

Primary Purpose

Knee Osteoarthritis, Morbid Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bariatric surgery followed by total knee replacement
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Knee Osteoarthritis focused on measuring Arthroplasty, Replacement, Knee, Bariatric Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Surgical weight loss

    Standard of Care

    Arm Description

    sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement

    dietary and lifestyle counseling prior to total knee replacement

    Outcomes

    Primary Outcome Measures

    Pain, mobility and quality of Life
    Knee Injury and Osteoarthritis Outcome Score (KOOS4)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 3, 2021
    Last Updated
    November 3, 2021
    Sponsor
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05120492
    Brief Title
    Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial
    Acronym
    OMEOSKO
    Official Title
    Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nova Scotia Health Authority

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Morbid Obesity
    Keywords
    Arthroplasty, Replacement, Knee, Bariatric Surgery

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgical weight loss
    Arm Type
    Experimental
    Arm Description
    sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement
    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Arm Description
    dietary and lifestyle counseling prior to total knee replacement
    Intervention Type
    Procedure
    Intervention Name(s)
    bariatric surgery followed by total knee replacement
    Intervention Description
    The only intervention is the randomization of the priority of the 2 procedures.
    Primary Outcome Measure Information:
    Title
    Pain, mobility and quality of Life
    Description
    Knee Injury and Osteoarthritis Outcome Score (KOOS4)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 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.

    12. IPD Sharing Statement

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