Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First?
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMemorial University of Newfoundland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI > or = 35, on surgical waitlist for a total knee arthroplasty and laparoscopic sleeve gastrectomy
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
laparoscopic sleeve gastrectomy
Procedure/SurgeryParticipants 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.
total knee arthroplasty
Procedure/SurgeryPatients 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.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Sleeve Gastrectomy then Knee ArthroplastyActive comparator 2 interventions
Group B: Knee Arthroplasty then Sleeve GastrectomyActive comparator 2 interventions
Trial outcomes
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.
Time frame
At baseline/enrollment followed by a year following each procedure.Secondary outcomes
1
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.
Time frame
At baseline/enrolment followed by a year after each procedure2
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.
Time frame
At baseline/enrolment in addition to a year following each procedure3
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.
Time frame
At 12 and 24 months following each intervention4
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.
Time frame
Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: