The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.

Detailed Description
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This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment. Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given. As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.

Official Title
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The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty

Conditions
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Blood Loss

Intervention / Treatment
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* Drug: Hemostatic Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single Knee replacement for arthritis of the knee Exclusion Criteria: No inflammatory arthritis (ie. Rheumatoid arthritis) No allergies to cow meat (bovine allergies No history of bleeding disorders
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemostatic Matrix<br>2 vials of Floseal applied once at the end of surgery | Drug: Hemostatic Matrix<br>* FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues 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.<br>* Other names: FloSeal, a thrombin and collagen based agent;|
| No Intervention: Control<br>No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin on Day 0 Compared to Preoperatively |  | preoperatively and on the day of surgery | 
| Change in Hemoglobin on Day 0 Compared to Preoperatively |  | preoperatively and day of surgery | 
| Change in Hemoglobin On Day 1 Compared to Preoperatively |  | preoperatively and one day after surgery | 
| Change in Hematocrit on Day 1 Compared to Preoperatively |  | preoperatively and 1 day after surgery | 
| Change in Hemoglobin on Day 2 Compared to Preoperatively |  | preoperatively and two days after surgery | 
| Change in Hematocrit on Day 2 Compared to Preoperatively |  | preoperatively and two days after surgery | 
| Drain Output |  | 24 hours postoperatively | 
| Autologous Amount of Transfusion |  | three days postoperatively | 
| Homologous Amount of Transfusion |  | three days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion on Day 3 |  | 3days postoperatively | 
| Visual Analog Pain Scale on Day 3 | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. | 3 days postoperatively | 
| Range of Motion at Six Weeks |  | 6 weeks postoperatively | 
| Visual Analog Pain Scale at 6 Weeks | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. | 6 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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To decrease blood loss during knee surgery