Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
Condition: Arthritis
MeSH terms: Arthritis; Hemorrhage
Intervention: Vitagel
Intervention description: Vitagel applied just prior to closure during primary total knee arthroplasty
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18 - 85 years

          -  Sex: Both male and female will be included. The male-to-female ratio will depend upon
             the patient population.

          -  Stable Health: At the time of surgery based on physical examination and medical
             history.

          -  Patient exhibited preoperative radiographic evidence of joint degeneration consistent
             with TKA that could not have been treated in non-operative fashion.

          -  Patient had severe knee pain and disability due to degenerative joint disease.

          -  Patient or patient's legal representative has signed the Informed Consent form. The
             patient is capable of making informed decisions regarding his/her healthcare.

        Exclusion Criteria:

          -  Patients with history of liver disease. Patients with liver dysfunction from cirrhosis
             or hepatitis may have impaired production of factors in the clotting cascade which may
             make these individuals more prone to bleed, especially with the use of anticoagulants.
             For this reason, these patients will also be excluded from this study if a baseline
             INR if greater than 1.3.

          -  Patients allergic to materials of bovine origin.

          -  Patients predonating autologous blood.

          -  Patients with a preoperative platelet count of less than 100,000.

          -  Patients undergoing bilateral or revision surgery.

          -  Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or
             anticoagulation use), or hypercoaguable disorder.

          -  Previous history of infection in the affected joint.

          -  Peripheral vascular disease.

          -  Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or
             mental handicap, etc.

          -  Patients with a previous history of venous thromboembolism, or other reason for
             requiring anticoagulation other than ASA 325 mg po BID and mechanical compression.