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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hopital du Sacre-Coeur de Montreal
• Collaborator: Baxter Healthcare Corporation
• Treatments: Hemostatics; Thrombin

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