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

Not Applicable

Not yet recruiting

• Conditions: Osteoarthritis of Knee; Arthroplasties, Knee Replacement; Sleeve Gastrectomy

• Registration Number: NCT06767787
• Lead Sponsor: Memorial University of Newfoundland

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-05
• Study First Posted: 2025-01-10
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Study Start: 2025-02
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
SF-36 Physical Function Component Score	At baseline/enrollment followed by a year following each procedure.	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.

Secondary Outcome Measures

Name	Time	Method
SF-36 Mental Component Score	At baseline/enrolment followed by a year after each procedure	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.
Knee Osteoarthritis Outcome Score (KOOS)	At baseline/enrolment in addition to a year following each procedure	The KOOS will be used to assess knee-specific function and symptoms at baseline as well as after each procedure.
Post-Operative Outcomes	At 12 and 24 months following each intervention	Post-operative outcomes following each intervention will be collected, including: hospital bed-day utilization, change in BMI and weight at 12 and 24 months.
Post-Operative Complications	Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.	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.

Trial Locations

Locations (2)

Health Sciences Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

St. Clare's Mercy Hospital; 🇨🇦 St. John's, Newfoundland and Labrador, Canada