Ortho Research

Clinical Trials

SWIFT TKA

Contact

Eric McVey

434-243-5382

edm9u@virginia.edu

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 eligible 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, bicompartamental 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.

Study Summary

TKA ONLY

  • Baseline 3 Months to 2 weeks before surgery (Control Arm Visit 1) Register to grant for blood draw / functional assessment only
  • SURGERY Register to grant Synovial Fluid Collection only.
  • 2 weeks ± 10 days (Control Arm Visit 2) Register to grant PA VISIT
  • 6 weeks ± 14 days (Control Arm Visit 3) paperwork for study and normal follow up
  • 6 months ± 1 month (Control Arm Visit 4) Register to grant for blood draw only
  • 12 months ± 1 month (Control Arm Visit 5) Register to grant for blood draw only
  • 24 months ± 1 month (Control Arm Visit 6) Register to grant for blood draw only

TKA AND BARIATRIC SURGERY

  • Baseline 3 Months to 2 weeks before Bariatric surgery (Test Arm Visit 1)
  • Bariatric Surgery
  • 1 month + 10 days (Test Arm Visit 2)
  • 6 months + 1 month (Test Arm Visit 3)
  • 9-13 months (Test Arm Visit 4)
  • TKA Surgery
  • 2 weeks ±10 days (Test Arm Visit 5) PA visit
  • 6 weeks ± 14 days (Test Arm Visit 6)
  • 6 months ± 1 month (Test Arm Visit 7)
  • 12 months ±1 month (Test Arm Visit 8)
  • 24 months ± 1 month (Test Arm Visit 9)

BARIATRIC SURGERY ONLY

  • Baseline 3 Months to 2 weeks before Bariatric surgery (Test Arm Visit 1)
  • Bariatric Surgery
  • 1 month + 10 days (Test Arm Visit 2)
  • 6 months + 1 month (Test Arm Visit 3)
  • 9-13 months (Test Arm Visit 4)
  • 18 months ± 1 month Same time frame as (Test Arm Visit 7)
  • 24 months ±1 month Same time frame as (Test Arm Visit 8)
  • 36 months ± 1 month Same time frame as (Test Arm Visit 9)

Payment

TKA only: $100 after Visits 1, 4, 5, 6

TKA and Bariatric: $100 after Visits 1,3, 4, 7, 8, 9

Complete vendor registration through UVA Procurement at: https://www.procurement.virginia.edu/pagevendorregistrationform

Contact Sarah Spangler (cc Eric McVey) with patient name, MRN, DOS, study visit

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