Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)

Study Overview
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Brief Summary
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The purpose of the SWIFT Trial is to answer two research questions. Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative and long-term outcomes of TKA in extreme obesity? Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?

Detailed Description
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Obese patients pursing a TKA procedure are typically encouraged to lose weight prior to the procedure as part of the patient's treatment plan. If the patient chooses to receive treatment for his or her obesity, the Orthopedic provider may refer the patient to a weight management provider. If a patient is eligible for TKA and meets the inclusion and exclusion criteria (containing BMI and corresponding comorbidity measures), he/she is eligible to participate in the study. In this study there will be two arms, a Test Arm in which patients undergo bariatric surgery prior to TKA and a Control Arm in which patients undergo TKA only. Patients will choose which arm they enter, based on whether or not they want to undergo surgical weight loss intervention prior to TKA. Test Arm: Participants will either undergo Laparoscopic Sleeve Gastrectomy or Laparoscopic Gastric Bypass surgery. Approximately 9-13 months post bariatric surgery, each test arm participant will be evaluated to determine if he/she is still a candidate or if the need for knee replacement no longer exists (or is delayed). If the participant is still a candidate, he/she will undergo TKA. Participants will complete nine (9) research visits over the course of 3.5 - 4 years, in addition to the standard of care visits required for bariatric surgery and TKA. Research visits will include study activities such as vital sign measurements, orthopedic outcome assessments, physical function assessments (i.e. stair climb, 400 meter walk, etc.), questionnaire completion, and synovial fluid collection if the patient has a TKA procedure performed. Control Arm: Participants in the control arm undergo a total knee replacement without surgical weight loss intervention and will complete six (6) research visits over the course of 2.5-3 years, in addition to the standard of care visits required for TKA. Research visits will include study activities such as vital sign measurements, orthopedic outcome assessments, physical function assessments (i.e. stair climb, 400 meter walk, etc.), questionnaire completion, and synovial fluid collection at the time of TKA. The study hypothesis is that weight loss induced by bariatric surgery prior to TKA will improve TKA outcomes in patients with extreme obesity. The study hypothesis will be met if one of the following outcomes is achieved: In >=20% of bariatric surgery patients, the need for TKA was negated or delayed for at least two years. A statistically significant superiority is found among those patients undergoing bariatric surgery + TKA versus those undergoing TKA only in at least two of the following domains at two years post TKA: Mobility (400 meter walk test) Osteoarthritis outcome (WOMAC total score) Knee orthopedic outcome (Knee Society score) Quality of life (PROMIS-29 Quality of Life Questionnaire) Osteoarthritic Pain (KOOS Pain) Patient Satisfaction (If you had to live the rest of your life with the symptoms you have now, how would you feel?)

Official Title
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Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)

Conditions
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Obesity, Osteoarthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 22-75 years. Subject is diagnosed with Non-inflammatory Degenerative Joint Disease(NIDJD). Subject is diagnosed with Morbid Obesity (Body Mass Index ≥ 40 kg/m2 or >35 kg/m2 with qualifying comorbid conditions such as obstructive sleep apnea or diabetes). Subject is a suitable candidate for cemented primary TKA with either resurfaced or non-resurfaced patellae. Subject is currently not bedridden. Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures. Subject has given voluntary, written informed consent to participate in this clinical investigation. Subject is comfortable with speaking, reading, and understanding questions and providing responses in an available translated language. Exclusion Criteria: Subject has undergone THA or contralateral knee within the past 6 months. Subject has had a contralateral amputation. Subject requires simultaneous bilateral TKA. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. Subject is currently experiencing radicular pain from the spine. Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication. Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease). Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). Subject has had previous bariatric surgery. Subject is medically or psychologically not suitable to undergo surgery. Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires. Subject has a medical condition with less than 2 years of life expectancy. Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test Arm<br>Test Arm participants will be enrolled in the standard of care bariatric surgery program and will undergo surgical weight loss through Laparoscopic Sleeve Gastrectomy or Laparoscopic Gastric Bypass. Approximately 9-13 months post surgery, each participant will be evaluated to determine if he/she is still eligible for a total knee replacement or if their need has been removed. If still eligible, participants will be enrolled in the standard of care TKA program and will undergo a TKA procedure. Participants will complete nine (9) research visits over 3.5-4 years. | |
| Control Arm<br>Control Arm participants will be enrolled in the standard of care TKA program and complete six (6) research visits over 2.5-3 years. This group of participants will undergo a TKA procedure without any surgical weight loss intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bariatric surgery patients who delay or no longer need TKA. | Participants in the Test Arm will undergo bariatric surgery prior to TKA. Determine if >=20% of Test Arm participants no longer need or delay the need for TKA. | 1 year post bariatric surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility assessment using the 400 Meter Walk test | Participants will be asked to complete 10 laps around cones that are 20 meters apart. During the test, participants will be asked to rate how hard they are walking and their level of knee pain. Heart rate and blood pressure will also be monitored. Mobility will be documented and analyzed to determine if there are changes throughout the course of the study. | 2 years post TKA surgery | 
| Pain, disability and joint stiffness will be assessed using the Osteoarthritis Outcomes Questionnaire (WOMAC total score) | The questionnaire is designed to assess pain, disability and joint stiffness in the osteoarthritis patient. Questionnaire answers will be documented and analyzed to determine if there are changes in pain, disability, and/or stiffness throughout the course of the study. | 2 years post TKA surgery | 
| Pain, function, range of motion and joint stability will be assessed using the American Knee Society Score. | The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Pain, function, range of motion, and joint stability will be documented and analyzed to determine if there are changes throughout the course of the study. | 2 years post TKA surgery | 
| Quality of life will be assessed using the PROMIS-29 Quality of Life Questionnaire. | Participants will be asked to complete a validated questionnaire known as PROMIS-29 to determine their quality of life. Answers to this questionnaire will be documented and analyzed to determine if there are changes in quality of life throughout the course of this study. | 2 years post TKA surgery | 
| Knee pain will be assessed using the Osteoarthritic Pain Questionnaire (KOOS) | The KOOS or Knee injury and Osteoarthritis Outcome Score are patient completed questionnaires which assess the patient's opinion regarding their knee and its associated osteoarthritis. Answers to this questionnaire will be documented and analyzed to determine if there are changes in knee pain throughout the course of this study. | 2 years post TKA surgery | 
| Change in Patient Satisfaction | Participants will be asked to answer the following question: If you had to live the rest of your life with the symptoms you have now, how would you feel? Answers to this question will be documented and analyzed to determine if there are changes in patient satisfaction throughout the course of this study. | 2 years post TKA surgery |