Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First?

NCT ID: NCT06767787

Last Updated: 2025-01-30

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2027-01-31

Brief Summary

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The goal of this study is to determine whether undergoing bariatric surgery before knee replacement leads to better outcomes compared to undergoing knee replacement before bariatric surgery. Our secondary goal is to compare complication rates between these groups to determine if there is a difference based on the order of the two procedures.

Participants will be randomly placed in one of two groups, with each undergoing both procedures but in opposite order. Quality of life will be assessed via questionnaires before and between each procedure, and rates of complications will also be documented to compare their rates between groups.

Detailed Description

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Conditions

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Osteoarthritis of Knee Arthroplasties, Knee Replacement Sleeve Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleeve Gastrectomy then Knee Arthroplasty

Participants in this arm will undergo laparoscopic sleeve gastrectomy followed by a total knee arthroplasty at least 1 year following the first procedure.

Group Type ACTIVE_COMPARATOR

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Participants undergoing laparoscopic sleeve gastrectomy (LSG) will be clinically assessed and provided consent to this procedure by one of the bariatric surgeons affiliated with the bariatric surgery program. LSG will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once they can tolerate a liquid diet. Patients will then attend regular follow-ups with their surgeons and the bariatric surgery program, in accordance with a standardized clinical pathway protocol.

total knee arthroplasty

Intervention Type PROCEDURE

Patients undergoing unilateral total knee arthroplasty (TKA) will be clinically assessed and provided consent to their procedure by an orthopaedic surgeon trained in joint arthroplasty. TKA will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once physiotherapy clears them. Patients will attend regular follow-ups with their surgeon in accordance with a standardized clinical pathway protocol.

Knee Arthroplasty then Sleeve Gastrectomy

Participants in this arm will undergo total knee arthroplasty followed by laparoscopic sleeve gastrectomy at least 1 year following the first procedure.

Group Type ACTIVE_COMPARATOR

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Participants undergoing laparoscopic sleeve gastrectomy (LSG) will be clinically assessed and provided consent to this procedure by one of the bariatric surgeons affiliated with the bariatric surgery program. LSG will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once they can tolerate a liquid diet. Patients will then attend regular follow-ups with their surgeons and the bariatric surgery program, in accordance with a standardized clinical pathway protocol.

total knee arthroplasty

Intervention Type PROCEDURE

Patients undergoing unilateral total knee arthroplasty (TKA) will be clinically assessed and provided consent to their procedure by an orthopaedic surgeon trained in joint arthroplasty. TKA will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once physiotherapy clears them. Patients will attend regular follow-ups with their surgeon in accordance with a standardized clinical pathway protocol.

Interventions

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laparoscopic sleeve gastrectomy

Participants undergoing laparoscopic sleeve gastrectomy (LSG) will be clinically assessed and provided consent to this procedure by one of the bariatric surgeons affiliated with the bariatric surgery program. LSG will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once they can tolerate a liquid diet. Patients will then attend regular follow-ups with their surgeons and the bariatric surgery program, in accordance with a standardized clinical pathway protocol.

Intervention Type PROCEDURE

total knee arthroplasty

Patients undergoing unilateral total knee arthroplasty (TKA) will be clinically assessed and provided consent to their procedure by an orthopaedic surgeon trained in joint arthroplasty. TKA will be performed at a local tertiary care hospital as either a day procedure or as an overnight stay if medically indicated. Patients will be discharged once physiotherapy clears them. Patients will attend regular follow-ups with their surgeon in accordance with a standardized clinical pathway protocol.

Intervention Type PROCEDURE

Other Intervention Names

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bariatric surgery sleeve gastrectomy knee arthroplasty knee replacement

Eligibility Criteria

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Inclusion Criteria

* BMI \> or = 35, on surgical waitlist for a total knee arthroplasty and laparoscopic sleeve gastrectomy

Exclusion Criteria

* a history of revision surgery, surgery for neoplastic disease, significant mental illness, ASA class \> 3 denoting absence of significant impact of comorbidities, and previous esophagogastric surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial University of Newfoundland

OTHER

Sponsor Role lead

Responsible Party

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Nick Smith

Dr. Nicholas Smith, Clinical Assistant Professor of Surgery (Orthopaedics)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

St. Clare's Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

Central Contacts

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Daniel G Muller, MD

Role: CONTACT

647-227-1629

Jack A Kerr, MD

Role: CONTACT

506-608-5005

Facility Contacts

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Daniel G Muller, MD, MHSc

Role: primary

6472271629

Jack A Kerr, MD

Role: backup

506-608-5005

Jack A Kerr, MD

Role: primary

506-608-5005

Daniel G Muller, MD, MHSc

Role: backup

647-227-1629

Other Identifiers

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HREB Application No. 38151

Identifier Type: -

Identifier Source: org_study_id

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