Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.

Detailed Description
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Study Design Study design and control methods: This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray. Treatment group: The subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator. Treatment allocation: All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired. Trial Population: The target sample size is 70 patients for both the treatment and control groups (140 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 140 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.

Official Title
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Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial

Conditions
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Osteoarthritis, Intraoperative Bleeding

Intervention / Treatment
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* Drug: Evicel Fibrin Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be male or female of any race Ages 18-80 years old Patients must be undergoing an elective, primary knee arthroplasty performed by the principal investigator Exclusion Criteria: Allergy or intolerance to the study materials Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology History of previous surgeries on the affected joint including previous arthroscopy (open surgeries) Women that are pregnant or may become pregnant Patient declines to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Control group. Will not receive the fibrin spray. | |
| Active Comparator: Treatment Group--Evicel Fibrin Spray<br>Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured. | Drug: Evicel Fibrin Spray<br>* 10cc syringe dose, once at the end of TKA<br>* Other names: Produced by OMRIX Biopharmaceuticals, Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary--Percent Change of Pre- to Post-Operative Hemoglobin | Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery. | Pre-operative to 1 month | 
| Total Blood Loss | Combination of intraoperative and postoperative blood loss for participants. | Collected during surgery and in first 2-3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Transfusions | The number of transfusions each patient receives during their postoperative hospitalization. | 3 days | 
| Postoperative Blood Loss | Measured as drainage output from postoperative drains during hospitalization. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Loss, Hemoglobin, Hematocrit, Blood Transfusions