An interventional study of laparoscopic sleeve gastrectomy and total knee arthroplasty in Osteoarthritis of Knee, Arthroplasties, Knee Replacement and Sleeve Gastrectomy, sponsored by Memorial University of Newfoundland. Not yet recruiting at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Memorial University of Newfoundland · Not applicable, Interventional, and Treatment
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 142 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Memorial University of Newfoundland is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
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 procedure
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 procedure
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 intervention
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.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Jan 2027, 23 months later.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 23 months is above that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Memorial University of Newfoundland