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

Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First? a Randomized Cross-over Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis of Knee; Sleeve Gastrectomy; Arthroplasties, Knee Replacement
• Intervention / Treatment: Procedure: laparoscopic sleeve gastrectomy; Procedure: total knee arthroplasty

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel G Muller, MD; Phone Number: 647-227-1629; Email: dmuller@mun.ca
• Study Contact Backup: Name: Jack A Kerr, MD; Phone Number: 506-608-5005; Email: jamkerr@mun.ca

Study Locations

• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B3X5
      • Health Sciences Centre
      • Contact: Jack A Kerr, MD; Phone Number: 506-608-5005; Email: jamkerr@mun.ca
      • Contact: Daniel G Muller, MD, MHSc; Phone Number: 6472271629; Email: dmuller@mun.ca
      • Contact: Daniel G Muller, MD, MHSc
      • Contact: Jack A Kerr, MD
    • St. John's, Newfoundland and Labrador, Canada, A1C5B8
      • St. Clare's Mercy Hospital
      • Contact: Jack A Kerr, MD; Phone Number: 506-608-5005; Email: jamkerr@mun.ca
      • Contact: Daniel G Muller, MD, MHSc
      • Contact: Jack A Kerr, MD
      • Contact: Daniel G Muller, MD, MHSc; Phone Number: 647-227-1629; Email: dmuller@mun.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: sleeve gastrectomy; bariatric surgery; 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.; Other Names: knee replacement; knee arthroplasty
Active Comparator: 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.	Procedure: 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.; Other Names: sleeve gastrectomy; bariatric surgery; 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.; Other Names: knee replacement; knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 Physical Function Component Score	The 36-Item Short-Form Survey (SF-36) Physical Function Component Score will be assessed 1 year after each procedure as a measure of quality of life.	At baseline/enrollment followed by a year following each procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 Mental Component Score	The 36-Item Short Form Survey's (SF-36) Mental Component Score will be used to assess participants' quality of life at baseline in addition to after each procedure.	At baseline/enrolment followed by a year after each procedure
Knee Osteoarthritis Outcome Score (KOOS)	The KOOS will be used to assess knee-specific function and symptoms at baseline as well as after each procedure.	At baseline/enrolment in addition to a year following each procedure
Post-Operative Outcomes	Post-operative outcomes following each intervention will be collected, including: hospital bed-day utilization, change in BMI and weight at 12 and 24 months.	At 12 and 24 months following each intervention
Post-Operative Complications	Post-operative complications will be surveilled every 3 months following each procedure, including: death from any cause, perioperative or postoperative complications that result in a delay in discharge (e.g., fracture, neurapraxia, sepsis, nosocomial infection, myocardial infarction, bowel obstruction, postoperative nausea & vomiting, venous thromboembolism, cerebrovascular event, and renal failure), wound complications (e.g., infections, hematomas, and dehiscence), prosthetic infection, and unplanned procedures and/or readmission.	Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.

Collaborators and Investigators

• Sponsor: Memorial University of Newfoundland

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 5, 2025
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: knee osteoarthritis; obesity; bariatric surgery; knee replacement; knee arthroplasty; laparoscopic sleeve gastrectomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nutrition Disorders; Arthritis; Joint Diseases; Rheumatic Diseases; Overnutrition; Body Weight; Overweight; Obesity; Osteoarthritis; Osteoarthritis, Knee; Obesity, Morbid
• Other Study ID Numbers: HREB Application No. 38151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No