Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

NCT ID: NCT01656759

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-08-31

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.

Conditions

Osteoarthritis; Intraoperative Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Control group. Will not receive the fibrin spray.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Evicel Fibrin Spray

Intervention Type: DRUG

10cc syringe dose, once at the end of TKA

Interventions

Evicel Fibrin Spray

10cc syringe dose, once at the end of TKA

Intervention Type: DRUG

Other Intervention Names

Produced by OMRIX Biopharmaceuticals, Ltd.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brett Levine, MD

Assistant Professor and Associate Residency Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett R Levine, MD

Role: PRINCIPAL_INVESTIGATOR

RUMC

Locations

Rush Oak Park Hospital

Oak Park, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 10565650 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11679600 (View on PubMed)

Other Identifiers

12032202-IRB01

Identifier Type: -

Identifier Source: org_study_id