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Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)
Recruiting
Trial ID: NCT02598531
Purpose
The purpose of the SWIFT Trial is to answer two research questions.
1. Does bariatric surgery before total knee arthroplasty (TKA) improve both perioperative
and long-term outcomes of TKA in extreme obesity?
2. Does bariatric surgery before TKA delay or possibly negate the need for arthroplasty?
Official Title
Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)
Eligibility
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.
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305