Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First?

Официальное название

Morbid Obesity and Severe Knee Osteoarthritis - Which Should Be Treated First? A Randomized Cross-over Study

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• SF-36 Physical Function Component Score [Срок оценки: At baseline/enrollment followed by a year following each procedure.]

Вторичные конечные точки (4)

• SF-36 Mental Component Score [Срок оценки: At baseline/enrolment followed by a year after each procedure]
• Knee Osteoarthritis Outcome Score (KOOS) [Срок оценки: At baseline/enrolment in addition to a year following each procedure]
• Post-Operative Outcomes [Срок оценки: At 12 and 24 months following each intervention]
• Post-Operative Complications [Срок оценки: Surveilled every 3 months post- each procedure, until the 12-month postoperative mark.]

Критерии участия

Критерии включения

• BMI > or = 35, on surgical waitlist for a total knee arthroplasty and laparoscopic sleeve gastrectomy

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Health Sciences Centre — St. John's
• St. Clare's Mercy Hospital — St. John's

Идентификаторы

NCT: NCT06767787 · HREB Application No. 38151

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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