Arthroplasties, Knee Replacement, Osteoarthritis of Knee, Sleeve Gastrectomy
Conditions
Keywords
knee osteoarthritis, bariatric surgery, laparoscopic sleeve gastrectomy, knee replacement, knee arthroplasty, obesity
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.
Interventions
PROCEDURElaparoscopic 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.
PROCEDUREtotal 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.
Sponsors
Memorial University of Newfoundland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactDaniel G Muller, MD
Backup ContactJack A Kerr, MD
Outcome results
None listed