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

NCT06767787 | Not Yet Recruiting

• 1 other identifier: HREB Application No. 38151
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteoarthritis of Knee; Arthroplasties, Knee Replacement; Sleeve Gastrectomy

Keywords

knee osteoarthritis; bariatric surgery; laparoscopic sleeve gastrectomy; knee replacement; knee arthroplasty; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• SF-36 Mental Component Score

  At baseline/enrolment followed by a year after each procedure

• Knee Osteoarthritis Outcome Score (KOOS)

  At baseline/enrolment in addition to a year following each procedure

• Post-Operative Outcomes

  At 12 and 24 months following each intervention

• Post-Operative Complications

  Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.

Study Arms (2)

Sleeve Gastrectomy then Knee Arthroplasty

ACTIVE COMPARATOR

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; Procedure: total knee arthroplasty

Knee Arthroplasty then Sleeve Gastrectomy

ACTIVE COMPARATOR

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; Procedure: total knee arthroplasty

Interventions

laparoscopic sleeve gastrectomy 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.

Also known as: bariatric surgery, sleeve gastrectomy

Knee Arthroplasty then Sleeve Gastrectomy; Sleeve Gastrectomy then Knee Arthroplasty

total knee arthroplasty 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.

Also known as: knee arthroplasty, knee replacement

Knee Arthroplasty then Sleeve Gastrectomy; Sleeve Gastrectomy then Knee Arthroplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (2)

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B3X5, Canada

Location

St. Clare's Mercy Hospital

St. John's, Newfoundland and Labrador, A1C5B8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity

Interventions

Bariatric Surgery; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Daniel G Muller, MD

CONTACT

647-227-1629; dmuller@mun.ca

Jack A Kerr, MD

CONTACT

506-608-5005; jamkerr@mun.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nicholas Smith, Clinical Assistant Professor of Surgery (Orthopaedics)

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 10, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)