Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Rush

Status and phase: Completed; Phase 3; Phase 2

Conditions: Osteoarthritis; Intraoperative Bleeding

Treatments: Drug: Evicel Fibrin Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01656759

12032202-IRB01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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73 participants in 2 patient groups

Control Group

No Intervention group

Description:

Control group. Will not receive the fibrin spray.

Treatment Group--Evicel Fibrin Spray

Active Comparator group

Description:

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.

Treatment:

Drug: Evicel Fibrin Spray