Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

Baxter

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis; Knee Replacement Surgery

Treatments: Procedure: Standard of Care; Drug: FLOSEAL Hemostatic Matrix + Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410240

611001

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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137 participants in 2 patient groups

Standard of Care (SoC)

Active Comparator group

Description:

SoC: conventional hemostatic techniques such as cautery and manual compression

Treatment:

Procedure: Standard of Care

FLOSEAL + Standard of Care (SoC)

Experimental group

Description:

FLOSEAL: consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression

Treatment:

Drug: FLOSEAL Hemostatic Matrix + Standard of care