Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

NCT ID: NCT05120492

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2027-07-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Knee Osteoarthritis Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Surgical weight loss

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

Group Type EXPERIMENTAL

bariatric surgery followed by total knee replacement

Intervention Type PROCEDURE

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

Standard of Care

dietary and lifestyle counseling prior to total knee replacement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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bariatric surgery followed by total knee replacement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nova Scotia Health

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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James Ellsmere, MD

Role: primary

902-473-1886

Other Identifiers

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41155

Identifier Type: -

Identifier Source: org_study_id

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