Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

NCT01410240 | Completed Phase 4 Results

• 1 other identifier: 611001
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively

  Pre-operative and 2 days post-operatively

• Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)

  * Proportion of Participants who have serious injuries (SIs) related to IP * Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP

  Throughout the study period, 1 year and 4 months

Secondary Outcomes (32)

• Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively

  Pre-operative and day 1 post-operatively

• Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively

  Pre-operative and day 3 post-operatively

• Change From Baseline in Hematocrit (Hct) at Postoperative Day 1

  Pre-operative and day 1 post-operatively

• Change From Baseline in Hematocrit (Hct) at Postoperative Day 2

  Pre-operative and day 2 post-operatively

• Change From Baseline in Hematocrit (Hct) at Postoperative Day 3

  Pre-operative and day 3 post-operatively

Study Arms (2)

Standard of Care (SoC)

ACTIVE COMPARATOR

SoC: conventional hemostatic techniques such as cautery and manual compression

Procedure: Standard of Care

FLOSEAL + Standard of Care (SoC)

EXPERIMENTAL

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

Drug: FLOSEAL Hemostatic Matrix + Standard of care

Interventions

Standard of Care PROCEDURE

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

Standard of Care (SoC)

FLOSEAL Hemostatic Matrix + Standard of care 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

Also known as: FLOSEAL

FLOSEAL + Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (12)

Cedars-Sinai Orthopedic Center

Los Angeles, California, 90042, United States

Location

Stanford Orthopedics

Redwood City, California, 94063, United States

Location

Colorado Orthopedic Consultants, PC

Englewood, Colorado, 80110, United States

Location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Florida Research Associates, LLC

DeLand, Florida, 32720, United States

Location

Shrock Orthopedic Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Phoenix Clinical Research, LLC

Tamarac, Florida, 33321, United States

Location

Joint Replacement Surgeons of Indiana Foundations

Mooresville, Indiana, 46158, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234-5500, United States

Location

The Rothman Institute, Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Hill Country Clinical Research, Inc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Standard of Care; FloSeal Matrix

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Maurice Bagot D'Arc, MD, Sr Medical Director Medical Affairs , BioSurgery
• Organization: Baxter BioScience

maurice_bagot_d'arc@baxter.com

Study Officials

• Ildiko Szabo, MD, MBA

  Baxter Innovations GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 5, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 6, 2014
• Results First Posted: June 6, 2014

Record last verified: 2014-05

Locations

US (12)