Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
|Osteoarthritis Intraoperative Bleeding||Drug: Evicel Fibrin Spray||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
|Official Title:||Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial|
- 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.
- 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.
- Total Transfusions [ Time Frame: 3 days ]The number of transfusions each patient receives during their postoperative hospitalization.
- Postoperative Blood Loss [ Time Frame: 3 days ]Measured as drainage output from postoperative drains during hospitalization.
|Study Start Date:||May 2012|
|Study Completion Date:||August 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
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.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656759
|United States, Illinois|
|Rush Oak Park Hospital|
|Oak Park, Illinois, United States, 60304|
|Principal Investigator:||Brett R Levine, MD||RUMC|