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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01891461

Enrollment

132

Registered

2013-07-03

Start date

2012-01-31

Completion date

2017-01-31

Last updated

2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Bleeding, Post-operative Bleeding

Keywords

total knee arthroplasty, post-operative bleeding, floseal

Brief summary

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

Detailed description

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)

Interventions

DRUGFloseal

Floseal (5 milliliters) will be applied to the exposed bone in the following order: around the margins of the tibia, the femur (anterior surface, intercondylar notch, exposed medial and lateral condyles) and around the un resurfaced portion of the patella. The other syringes (each of 5 milliliters) will then be applied to the supra-patellar synovium and into the medial and lateral gutters of the knee. No Floseal will be applied outside the knee joint capsule.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Need of transfusion post-op (yes/no, how many)	post op day 1 to 7

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026