Trial Search Results

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

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?

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Geisinger Clinic

Collaborator: Hospital for Special Surgery, New York

Stanford Investigator(s):

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:

   - Contralateral knee has already undergone TKA.

   - 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 is medically 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

22 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting