Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656759
• Other study ID #: 12032202-IRB01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2012
• Last updated: January 11, 2016
• Start date: May 2012
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intraoperative Bleeding
• Osteoarthritis

Intervention

Drug:
• Evicel Fibrin Spray
10cc syringe dose, once at the end of TKA

Locations

Country	Name	City	State
United States	Rush Oak Park Hospital	Oak Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;8 — View Citation

Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Sur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Total Blood Loss	Combination of intraoperative and postoperative blood loss for participants.	Collected during surgery and in first 2-3 days after surgery	No
Secondary	Total Transfusions	The number of transfusions each patient receives during their postoperative hospitalization.	3 days	No
Secondary	Postoperative Blood Loss	Measured as drainage output from postoperative drains during hospitalization.	3 days	No