Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty (SWIFT Trial)
Trial ID or NCT#
NCT02598531
Status
RECRUITING
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 Criteria
Ages Eligible for Study: 22 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
View on ClinicalTrials.gov
