Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
Condition: Knee Replacement Surgery; Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Standard of Care; FLOSEAL Hemostatic Matrix + Standard of care
Intervention description: Conventional hemostatic techniques, such as cautery and manual compression, will be used.; FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes.
+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used
Intervention MeSH terms: Hemostatics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of
      care for hemostasis in subjects undergoing total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is 18 to 80 years of age inclusive at the time of screening

          -  Participant is planned for primary unilateral total knee arthroplasty

          -  Participant has signed the informed consent form

          -  Participant is in stable health (i.e., able to undergo surgery and participate in a
             follow-up program based on physical examination and medical history)

          -  Participant has a preoperative Hgb level > 10 g/dL

          -  If female of childbearing potential, the participant presents with a negative urine
             pregnancy test and agrees to employ adequate birth control measures for the duration
             of the study

          -  Participant is willing and able to comply with the requirements of the protocol

        Exclusion Criteria:

          -  Participant has had a previous total or partial knee arthroplasty or any surgery on
             the knee within the previous 6 months

          -  Participant has osteonecrosis or arthrotomy within the last year

          -  Participant has prior or current hardware in target knee

          -  Participant has had injections in the knee:

               1. Steroids within the 3 months prior to scheduled surgery,

               2. Synvisc, Hyalin, etc. within the 6 months prior to scheduled surgery

          -  Participant has had general surgery within 3 months

          -  Participant has rheumatoid arthritis or any other inflammatory or traumatic bone
             injuries to the knee within the 12 months prior to scheduled surgery

          -  Participant has allergies to products of bovine origin

          -  Participant has a history of bleeding, platelet, or bone marrow disorders

          -  Participant has donated more than 1 unit of blood donation in the 3 weeks prior to
             surgery

          -  Participant has a history of a coagulation disorder

          -  Participant is currently taking dipyridamole/ASA (Aggrenox) and/or enoxaparin
             (Lovenox)

          -  Participant has been treated with aspirin or Warfarin (Coumadin) or clopidogrel
             (Plavix) within 7 days prior to surgery

          -  Participant is not permitted to remain without his/her anti-coagulant regimen (e.g.
             Plavix) for 48 hours postoperatively

          -  Participant has taken nonsteroidal anti-inflammatory agents or herbal supplements
             within 7 days of surgery

          -  Participant has a history of substance abuse (alcohol, drugs) or is an active smoker

          -  Participant has liver cirrhosis

          -  Participant has erythropoietin agonist/stimulating agent within 90 days prior to
             surgery

          -  Participant has an active infection or previous history of infection in the affected
             joint within the previous 6 months

          -  Participant has participated in another clinical study involving an investigational
             product (IP) or device within 30 days prior to study enrollment or is scheduled to
             participate in another clinical study involving an IP or device during the course of
             this study