Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01656759
Recruitment Status : Completed
First Posted : August 3, 2012
Results First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Information provided by (Responsible Party):
Brett Levine, MD, Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Intraoperative Bleeding Drug: Evicel Fibrin Spray Phase 2 Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial
Study Start Date : May 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control Group
Control group. Will not receive the fibrin spray.
Active Comparator: Treatment Group--Evicel Fibrin Spray

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
10cc syringe dose, once at the end of TKA
Other Name: Produced by OMRIX Biopharmaceuticals, Ltd.

Primary Outcome Measures :
  1. Primary--Percent Change of Pre- to Post-Operative Hemoglobin [ Time Frame: Pre-operative to 1 month ]
    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.

  2. Total Blood Loss [ Time Frame: Collected during surgery and in first 2-3 days after surgery ]
    Combination of intraoperative and postoperative blood loss for participants.

Secondary Outcome Measures :
  1. Total Transfusions [ Time Frame: 3 days ]
    The number of transfusions each patient receives during their postoperative hospitalization.

  2. Postoperative Blood Loss [ Time Frame: 3 days ]
    Measured as drainage output from postoperative drains during hospitalization.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01656759

United States, Illinois
Rush Oak Park Hospital
Oak Park, Illinois, United States, 60304
Sponsors and Collaborators
Rush University Medical Center
Principal Investigator: Brett R Levine, MD RUMC

Publications of Results:
Responsible Party: Brett Levine, MD, Assistant Professor and Associate Residency Director, Rush University Medical Center Identifier: NCT01656759     History of Changes
Other Study ID Numbers: 12032202-IRB01
First Posted: August 3, 2012    Key Record Dates
Results First Posted: February 9, 2016
Last Update Posted: February 9, 2016
Last Verified: January 2016

Keywords provided by Brett Levine, MD, Rush University Medical Center:
Blood Loss
Blood Transfusions

Additional relevant MeSH terms:
Blood Loss, Surgical
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Intraoperative Complications
Fibrin Tissue Adhesive