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

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:

• Efficacy (during hospital stay)

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