Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Number of bariatric surgery patients who delay or no longer need TKA.
研究概览
简要总结
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?
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of bariatric surgery patients who delay or no longer need TKA.
时间窗: 1 year post bariatric surgery
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.
次要结局
- Mobility assessment using the 400 Meter Walk test(2 years post TKA surgery)
- Pain, disability and joint stiffness will be assessed using the Osteoarthritis Outcomes Questionnaire (WOMAC total score)(2 years post TKA surgery)
- Pain, function, range of motion and joint stability will be assessed using the American Knee Society Score.(2 years post TKA surgery)
- Quality of life will be assessed using the PROMIS-29 Quality of Life Questionnaire.(2 years post TKA surgery)
- Knee pain will be assessed using the Osteoarthritic Pain Questionnaire (KOOS)(2 years post TKA surgery)
- Change in Patient Satisfaction(2 years post TKA surgery)