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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve Gastrectomy then Knee Arthroplasty | Active Comparator | Participants in this arm will undergo laparoscopic sleeve gastrectomy followed by a total knee arthroplasty at least 1 year following the first procedure. |
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| Knee Arthroplasty then Sleeve Gastrectomy | Active Comparator | Participants in this arm will undergo total knee arthroplasty followed by laparoscopic sleeve gastrectomy at least 1 year following the first procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline/enrollment followed by a year following each procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline/enrolment followed by a year after each procedure |
| Knee Osteoarthritis Outcome Score (KOOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel G Muller, MD | Contact | 647-227-1629 | dmuller@mun.ca | |
| Jack A Kerr, MD | Contact | 506-608-5005 | jamkerr@mun.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | St. John's | Newfoundland and Labrador | A1B3X5 | Canada |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
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| 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. |
|
|
The KOOS will be used to assess knee-specific function and symptoms at baseline as well as after each procedure. |
| 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. | 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. | Surveilled every 3 months post- each procedure, until the 12-month postoperative mark. |
| St. Clare's Mercy Hospital | St. John's | Newfoundland and Labrador | A1C5B8 | Canada |
|
| D012216 |
| Rheumatic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019643 |
| Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |