Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
Intraoperative Bleeding, Post-operative Bleeding
About this trial
This is an interventional treatment trial for Intraoperative Bleeding focused on measuring total knee arthroplasty, post-operative bleeding, floseal
Eligibility Criteria
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
Sites / Locations
- Hopital du sacre coeur de montreal
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Floseal
standard of care
Floseal will be administered during the procedure and prior to release of the tourniquet (if used PRN during the cementing procedure (±10 minutes)) and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissue by the use of a delivery syringe. Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface. Preparation of Floseal requires mixing 5,000 US units of package thrombin (bovine-derived) made up to 5 milliliters of saline solution, to the Gelatin Matrix solution. In this study, 2-4 vials (15-20 mls total) will be used.
For patients randomized to the control arm, the surgery will proceed in an otherwise identical fashion (with release of the tourniquet if used PRN during cementing procedure (±10 minutes)) and hemostasis followed by drain insertion and wound closure.