Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Drug: Evicel Fibrin Spray
|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|
- 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--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.
|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)|
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 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
|Contact: Brett R Levine, MDfirstname.lastname@example.org|
|Contact: Samuel J Pera, BSemail@example.com|
|United States, Illinois|
|Rush Oak Park Hospital||Recruiting|
|Oak Park, Illinois, United States, 60304|
|Principal Investigator: Brett R Levine, MD|
|Principal Investigator:||Brett R Levine, MD||RUMC|