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NCT Number: NCT06767787

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

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.

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Key information

Conditions

Osteoarthritis of Knee Arthritis Arthroplasties, Knee Replacement Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Osteoarthritis, Knee Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Sleeve Gastrectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: bariatric surgery, sleeve gastrectomy

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.

Other names: knee arthroplasty, knee replacement

Primary outcomes

  1. SF-36 Physical Function Component Score

    Time frame: 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 outcomes

  1. SF-36 Mental Component Score

    Time frame: 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.

  2. Knee Osteoarthritis Outcome Score (KOOS)

    Time frame: 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.

  3. Post-Operative Outcomes

    Time frame: 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.

  4. Post-Operative Complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel G Muller, MD

CONTACT

[email protected]

647-227-1629

Jack A Kerr, MD

CONTACT

[email protected]

506-608-5005

Sponsors and collaborators

Lead sponsor

Memorial University of Newfoundland

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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