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

Trial details

Who runs it

Geisinger Clinic

Trial code

NCT02598531

Record updated

22 January 2025

Original description

The purpose of the SWIFT Trial is to answer two research questions.Read full original descriptionShow less

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?

Inclusion: 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: Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee; Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication; Subject has had previous bariatric surgery; Subject is medically or psychologically not suitable to undergo surgery; Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months; 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 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 undergone THA or contralateral knee within the past 6 months; Subject has had a contralateral amputation; Subject requires simultaneous bilateral TKA; Subject is currently experiencing radicular pain from the spine; Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.); Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language.

ClinicalTrials.gov NCT02598531