Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

Completed · Phase 4

Conditions studied: Knee Replacement Surgery, Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01410240

Run by

Baxter Healthcare Corporation

People needed

137

Starts

2011-09-01

Expected to finish

2013-01-01

Last updated by the study team

2014-06-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• Steroids within the 3 months prior to scheduled surgery,
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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