Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Phase 2

Completed

Conditions: Osteoarthritis
Intraoperative Bleeding

Interventions: Drug: Evicel Fibrin Spray

Registration Number: NCT01656759

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 73

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group--Evicel Fibrin Spray	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.

Primary Outcome Measures

Name	Time	Method
Total Blood Loss	Collected during surgery and in first 2-3 days after surgery	Combination of intraoperative and postoperative blood loss for participants.
Primary--Percent Change of Pre- to Post-Operative Hemoglobin	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.

Secondary Outcome Measures

Name	Time	Method
Total Transfusions	3 days	The number of transfusions each patient receives during their postoperative hospitalization.
Postoperative Blood Loss	3 days	Measured as drainage output from postoperative drains during hospitalization.