Clinical trial NCT01656759: Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Official title: Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Intraoperative Bleeding
Keywords: Blood Loss
Hemoglobin
Hematocrit
Blood Transfusions
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary--Percent Change of Pre- to Post-Operative Hemoglobin
timeFrame: Pre-operative to 1 month
measure: Total Blood Loss
timeFrame: Collected during surgery and in first 2-3 days after surgery
Secondary outcomes:
measure: Total Transfusions
timeFrame: 3 days
measure: Postoperative Blood Loss
timeFrame: 3 days
Other outcomes:
Locations:
city: Oak Park
country: United States
facility: Rush Oak Park Hospital
state: Illinois
Study officials:
affiliation: RUMC
name: Brett R Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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;81(11):1580-8. doi: 10.2106/00004623-199911000-00010.
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 Surg Am. 2001 Oct;83(10):1503-5. doi: 10.2106/00004623-200110000-00007.