Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Brett Levine, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01656759
First received: June 14, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Osteoarthritis
Intraoperative Bleeding
Drug: Evicel Fibrin Spray
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Primary--Need for peri-operative blood transfusions and intra-op and post-op blood loss comparisons [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Record number of transfusions and changes in hemoglobin and hematocrit levels.

  • Total blood loss [ Time Frame: Collected during surgery and in first 2-3 days after surgery ] [ Designated as safety issue: No ]
    Intra-op and post-op blood loss will be measured and compared between the two treatment arms to look for differences.


Secondary Outcome Measures:
  • Secondary--Patient ROM, thigh and calf circumference (measure of swelling) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Record post-operative swelling by measuring both thigh/leg circumference at discharge, 2 weeks and 6 weeks post-op follow ups. Record patient's range of motion at discharge, 2 weeks and 6 weeks post-op follow ups. Compare both to patient pre-op values.

  • Knee Scores [ Time Frame: Will collecte pre-op and postop scores ] [ Designated as safety issue: No ]
    Functional outcomes (KSS scores, UCLA score and EQ5D)will be measured to help identify successful surgeries both subjectively and objectively.


Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656759

Contacts
Contact: Brett R Levine, MD 3124322466 brettlevinemd@gmail.com
Contact: Samuel J Pera, BS 7089450519 samuelpera@gmail.com

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

Publications:
Responsible Party: Brett Levine, MD, Assistant Professor and Associate Residency Director, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01656759     History of Changes
Other Study ID Numbers: 12032202-IRB01
Study First Received: June 14, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Blood Loss
Hemoglobin
Hematocrit
Blood Transfusions

Additional relevant MeSH terms:
Osteoarthritis
Blood Loss, Surgical
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hemorrhage
Pathologic Processes
Intraoperative Complications
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014