Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01410240
First received: August 1, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Knee Replacement Surgery
Osteoarthritis
Other: Standard of Care
Drug: FLOSEAL Hemostatic Matrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Single-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of FLOSEAL for Hemostasis in Primary Unilateral Total Knee Arthroplasty (TKA)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Change in hemoglobin (Hgb) level (g/dL) at Day 2 post-operatively [ Time Frame: 2 days post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hemoglobin levels (g/dL) at Day 1 and 3 post-operatively [ Time Frame: 1-3 days post-operatively ] [ Designated as safety issue: No ]
  • Hematocrit (Hct) levels (%) at Day 1, 2 and 3 post-operatively [ Time Frame: 1-3 days post-operatively ] [ Designated as safety issue: No ]
  • Total tourniquet time (in minutes) [ Time Frame: Intra-operatively (on day of surgery = Day 0) ] [ Designated as safety issue: No ]
  • Amount of FLOSEAL applied (mL) [ Time Frame: Intra-operatively (Day 0) ] [ Designated as safety issue: No ]
  • Duration of surgery [ Time Frame: Time from first incision to complete wound closure (Day 0) ] [ Designated as safety issue: No ]
  • Transfusion requirements (units) [ Time Frame: Intra-operatively (Day 0) ] [ Designated as safety issue: No ]
  • Total drain output (mL) at Day 1 post-operatively [ Time Frame: 1 day post-operatively ] [ Designated as safety issue: No ]
  • Pain management [ Time Frame: Measured pre-operatively (Day -1 to Day 0) and post-operatively on a weekly basis ] [ Designated as safety issue: No ]
  • Visual Analogue Scale (VAS) pain scores [ Time Frame: Measured pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6 ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Universities (WOMAC) function subscale index [ Time Frame: Measured pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6 ] [ Designated as safety issue: No ]
  • Quality of Life (Short Form 36 health survey) [ Time Frame: Measured pre-operatively (Day -1 to Day 0), and post-operatively at Week 1, 2 and 6 ] [ Designated as safety issue: No ]
  • Duration of hospital stay (days) [ Time Frame: 1 to 3 days ] [ Designated as safety issue: No ]
  • Patient rehabilitation [ Time Frame: Assessed post-operatively on a weekly basis until Week 6 ] [ Designated as safety issue: No ]
  • Serious injuries, non-serious AEs and wound complications (ie, hematoma, cellulitis, dehiscence, superficial or deep infection, and persistent drainage) [ Time Frame: Assessed daily, from surgery until end of study (= Week 6 (Day 42 +/-3) post-operatively) ] [ Designated as safety issue: Yes ]

Enrollment: 137
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Product + Standard of Care
55 evaluable subjects
Drug: FLOSEAL Hemostatic Matrix
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.
Other Name: FLOSEAL
Standard of Care (alone)
55 evaluable subjects
Other: Standard of Care
Conventional hemostatic techniques, such as cautery and manual compression, will be used.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject has had a previous total or partial knee arthroplasty or any surgery on the knee within the previous 6 months
  • Subject has osteonecrosis or arthrotomy within the last year
  • Subject has prior or current hardware in target knee
  • Subject 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
  • Subject has had general surgery within 3 months
  • Subject has rheumatoid arthritis or any other inflammatory or traumatic bone injuries to the knee within the 12 months prior to scheduled surgery
  • Subject has allergies to products of bovine origin
  • Subject has a history of bleeding, platelet, or bone marrow disorders
  • Subject has donated more than 1 unit of blood donation in the 3 weeks prior to surgery
  • Subject has a history of a coagulation disorder
  • Subject is currently taking dipyridamole/ASA (Aggrenox) and/or enoxaparin (Lovenox)
  • Subject has been treated with aspirin or Warfarin (Coumadin) or clopidogrel (Plavix) within 7 days prior to surgery
  • Subject is not permitted to remain without his/her anti-coagulant regimen (e.g. Plavix) for 48 hours postoperatively
  • subject has taken nonsteroidal anti-inflammatory agents or herbal supplements within 7 days of surgery
  • Subject has a history of substance abuse (alcohol, drugs) or is an active smoker
  • Subject has liver cirrhosis
  • Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery
  • Subject has an active infection or previous history of infection in the affected joint within the previous 6 months
  • Subject 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410240

Locations
United States, California
Cedars-Sinai Orthopedic Center
Los Angeles, California, United States, 90042
Stanford Orthopedics
Redwood City, California, United States, 94063
United States, Colorado
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States, 80110
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20017
United States, Florida
Florida Research Associates, LLC
DeLand, Florida, United States, 32720
Phoenix Clinical Research, LLC
Tamarac, Florida, United States, 33321
United States, Indiana
St Francis Hospital-Mooresville, Center for Hip & Knee Surgery
Mooresville, Indiana, United States, 46158
Joint Replacement Surgeons of Indiana Foundations
Mooresville, Indiana, United States, 46158
United States, New Jersey
Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234-5500
Princeton Orthopedic Associates
Princeton, New Jersey, United States, 08540
United States, North Carolina
PGM Research
Wilmington, North Carolina, United States, 28401
United States, Pennsylvania
Jefferson Medical College, The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Hospital of the University of Pennsylvania, Dept. of Orthopedics
Philadelphia, Pennsylvania, United States, 19107
Temple University
Philadelphia, Pennsylvania, United States, 19140
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Guenter Zuelow, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01410240     History of Changes
Other Study ID Numbers: 611001
Study First Received: August 1, 2011
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014