Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT01891461
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01891461
Study Brief:
Protocol Section:
NCT01891461