Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR

A Prospective, Randomized Study to Compare the Addition of Granules of Gelatine + Thrombin to Our Standard of Care (SOC) to Control Post Operative Bleeding in Total Knee Replacement

The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.

A prospective randomized single-blind clinical trial will be conducted at the Hôpital du Sacré-Coeur de Montréal and Hôpital Jean-Talon. All patients admitted for total knee arthroplasty (TKA) between January 2012 and September 2013 Outcome variable: Patient receiving Floseal or SOC

Variables under study:

Primary end point:

Need of transfusion post-op (yes/no, how many)

Patient will be transfused if :

Hg < 80 g/L plus if patient is symptomatic: orthostatic hypotension, tachycardia (pulse> 100/min, hypotension (< 90/60), hx : CVA, CAD)

Secondary end point:

1. Efficacy (during hospital stay)

   • Pre-op and post-op Hg (> 100; 80-100; <80)
   • Hemovac blood drainage (ml)
   • Per operative bleeding (ml)

2. Safety (Follow up: 6wks, 6 ms, 12 ms, 24 ms)

   • Post-op complications: infection, pain, oedema, allergic reaction.
   • Functional outcomes: Knee Society Score (KSS), Western Ontario and McMaster Universities questionnaire (WOMAC), International knee documentation committee form (IKDC)

Inclusion Criteria:

• All subjects above 18 years old admitted for a TKA between January 2012 and September 2013at Hôpital du Sacré-Coeur de Montréal (HSCM) and Hôpital Jean-Talon (HJT), Montréal, Quebec, Canada.

  • TKA done without the use of a tourniquet except while cementing only (±10 minutes)
  • TKA done with Smith and Nephew "Genesis II" or Zimmer "NexGen" total knee replacement implants

Exclusion Criteria:

• • Prior osteotomy or knee surgery within last 6-8 wks

  • Active, local infection or systemic infection
  • Participation in any other pharmaceutical or clinical investigation
  • Bleeding disorders (Hemophilia A, Hemophilia B, Von Willebrand disease, factor VIII deficiency, Vitamin K deficiency, Thrombocytopenia (platelets < 50 x 109 per litre)
  • Patients with known allergies to materials of bovine origin