Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
Condition: Arthritis
MeSH terms: Arthritis; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitagel® is an FDA approved class III medical device. It is a surgical hemostat, which has
      been shown to control bleeding during orthopaedic, cardiac, hepatic, and general surgical
      procedures. The product is a thrombin/collagen suspension which works in combination with the
      patient's own plasma to form a fibrin/collagen clot.

      The present prospective, randomized controlled trial is designed to evaluate the efficacy of
      Vitagel® for reducing blood loss and pain in patients managed with unilateral total knee
      arthroplasty (TKA). It is hypothesized that the use of Vitagel® may lead to less blood filled
      knees, and thus to a greater improvement in postoperative pain scores when compared to the
      control group. The two arms of the study will include:

        1. experimental group in which Vitagel® is used unilateral TKA

        2. control group representing our current standard of care (no Vitagel®)

      A comparison of the functional and clinical results between these two groups will be
      conducted using several outcome measures including the KOOS, SF-12 version2 and pain scores
      through the previously IRB approved OrthoMidas registry. The primary variable of interest is
      blood loss, based on hemoglobin drop during the postoperative hospital stay. Of secondary
      interest will be; 1) pain levels in the PACU, 2) pain scores for all postoperative days, 3)
      average pain for the entire hospital stay, 4) length of stay, 5) patient satisfaction at
      discharge, 4 weeks postoperative, and 12 weeks postoperative, and 6) functional scores at 4
      and 12 weeks postoperative.
    

Detailed description: 
      This is a prospective, single-center, randomized, double-blinded, clinical trial involving
      three orthopaedic surgeons who perform total knee replacement. The proposed study is optimal
      for obtaining clinical and functional comparisons between TKA surgical procedures utilizing
      conventional practices (control) and TKA utilizing Vitagel®, a surgical hemostat used to
      control bleeding and facilitate healing. The study will include patients that are receiving a
      unilateral primary TKA.

      Fifty cases will be assigned to each arm of the study (total 100 cases). This sample size was
      estimated using an alpha of 0.05 (conventional for all studies) and a beta of 0.80
      (recommended for superiority studies). The standard deviation is based on a study conducted
      by the PI at the Cleveland Clinic in an IRB approved retrospective project in 2007, and will
      provide in excess of 80 percent statistical power in detecting less than a 100 ml difference
      in blood loss between the two groups.

      The study will be conducted at the Cleveland Clinic (Cleveland, OH). The patients will not be
      informed of their treatment assignment, and the research investigator making observations and
      recording the data postoperatively will also be blinded to their treatment assignment. The
      placement of patients into treatment arms will be based on random drawing of sealed
      envelopes. An assessment of blinding will be conducted at the conclusion of the study by
      asking patients what treatment they think that they received.

      Data will be collected at four timepoints, including preoperatively, during the hospital
      stay, 4 weeks postoperatively, and 12 weeks postoperatively. Preoperative data collected will
      include baseline SF-12, KOOS, hemoglobin and hematocrit levels, and pain scores. Data
      collected in the hospital will include hemoglobin and hematocrit levels, pain scores,
      narcotics usage, length of stay, and patient satisfaction at discharge. The SF-12, KOOS, pain
      scores, and patient satisfaction will be collected utilizing the 4 week (±2 weeks) standard
      of care postoperative visit. Patients are not always seen at the 12 week (±4 weeks)
      postoperative timepoint as standard of care. To collect these data, patients will be mailed
      the SF-12, KOOS, pain scores, patient satisfaction, and blinding assessment questionnaires.
      Patients not responding to the initial mailer will be contacted by phone and sent a second
      packet of questionnaires.
    

Intervention name(s): Vitagel
Intervention type(s): Device
Intervention description(s): Vitagel applied just prior to closure during primary total knee arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment