Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

NCT ID: NCT01410240

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.

Conditions

Knee Replacement Surgery; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care (SoC)

SoC: conventional hemostatic techniques such as cautery and manual compression

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: PROCEDURE

Conventional hemostatic techniques, such as cautery and manual compression, will be used.

FLOSEAL + Standard of Care (SoC)

FLOSEAL: consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.

SoC: conventional hemostatic techniques such as cautery and manual compression

Group Type: EXPERIMENTAL

FLOSEAL Hemostatic Matrix + Standard of care

Intervention Type: DRUG

FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes.

+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used

Interventions

Standard of Care

Conventional hemostatic techniques, such as cautery and manual compression, will be used.

Intervention Type: PROCEDURE

FLOSEAL Hemostatic Matrix + Standard of care

FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes.

+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used

Intervention Type: DRUG

Other Intervention Names

FLOSEAL

Eligibility Criteria

Inclusion Criteria

• Participant is 18 to 80 years of age inclusive at the time of screening
• Participant is planned for primary unilateral total knee arthroplasty
• Participant has signed the informed consent form
• Participant is in stable health (i.e., able to undergo surgery and participate in a follow-up program based on physical examination and medical history)
• Participant has a preoperative Hgb level > 10 g/dL
• If female of childbearing potential, the participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study
• Participant is willing and able to comply with the requirements of the protocol

Exclusion Criteria

• Participant has had a previous total or partial knee arthroplasty or any surgery on the knee within the previous 6 months
• Participant has osteonecrosis or arthrotomy within the last year
• Participant has prior or current hardware in target knee
• Participant has had injections in the knee:

1. Steroids within the 3 months prior to scheduled surgery,

2. Synvisc, Hyalin, etc. within the 6 months prior to scheduled surgery

• Participant has had general surgery within 3 months
• Participant has rheumatoid arthritis or any other inflammatory or traumatic bone injuries to the knee within the 12 months prior to scheduled surgery
• Participant has allergies to products of bovine origin
• Participant has a history of bleeding, platelet, or bone marrow disorders
• Participant has donated more than 1 unit of blood donation in the 3 weeks prior to surgery
• Participant has a history of a coagulation disorder
• Participant is currently taking dipyridamole/ASA (Aggrenox) and/or enoxaparin (Lovenox)
• Participant has been treated with aspirin or Warfarin (Coumadin) or clopidogrel (Plavix) within 7 days prior to surgery
• Participant is not permitted to remain without his/her anti-coagulant regimen (e.g. Plavix) for 48 hours postoperatively
• Participant has taken nonsteroidal anti-inflammatory agents or herbal supplements within 7 days of surgery
• Participant has a history of substance abuse (alcohol, drugs) or is an active smoker
• Participant has liver cirrhosis
• Participant has erythropoietin agonist/stimulating agent within 90 days prior to surgery
• Participant has an active infection or previous history of infection in the affected joint within the previous 6 months
• Participant has participated in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or device during the course of this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ildiko Szabo, MD, MBA

Role: STUDY_DIRECTOR

Baxter Innovations GmbH

Locations

Cedars-Sinai Orthopedic Center

Los Angeles, California, United States

Stanford Orthopedics

Redwood City, California, United States

Colorado Orthopedic Consultants, PC

Englewood, Colorado, United States

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Florida Research Associates, LLC

DeLand, Florida, United States

Shrock Orthopedic Research, LLC

Fort Lauderdale, Florida, United States

Phoenix Clinical Research, LLC

Tamarac, Florida, United States

Joint Replacement Surgeons of Indiana Foundations

Mooresville, Indiana, United States

Rothman Institute

Egg Harbor, New Jersey, United States

The Rothman Institute, Philadelphia

Philadelphia, Pennsylvania, United States

Temple University

Philadelphia, Pennsylvania, United States

Hill Country Clinical Research, Inc.

Austin, Texas, United States

Countries

United States

Other Identifiers

611001

Identifier Type: -

Identifier Source: org_study_id