Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: laparoscopic sleeve gastrectomy, total knee arthroplasty.
- Who it may be relevant to
- Registry conditions: Osteoarthritis of Knee, Arthroplasties, Knee Replacement, Sleeve Gastrectomy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First? A Randomized Cross-over Study
Overview
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
- Procedure laparoscopic 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 prog - Procedure total 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.
Primary outcome measures
- SF-36 Physical Function Component Score [Time frame: At baseline/enrollment followed by a year following each procedure.]
Secondary outcome measures (4)
- SF-36 Mental Component Score [Time frame: At baseline/enrolment followed by a year after each procedure]
- Knee Osteoarthritis Outcome Score (KOOS) [Time frame: At baseline/enrolment in addition to a year following each procedure]
- Post-Operative Outcomes [Time frame: At 12 and 24 months following each intervention]
- Post-Operative Complications [Time frame: Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Health Sciences Centre — St. John's
- St. Clare's Mercy Hospital — St. John's
Identifiers
NCT: NCT06767787 · HREB Application No. 38151