Clinical trial NCT01410240: Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Replacement Surgery
Osteoarthritis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
timeFrame: Pre-operative and 2 days post-operatively
measure: Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
timeFrame: Throughout the study period, 1 year and 4 months
Secondary outcomes:
measure: Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively
timeFrame: Pre-operative and day 1 post-operatively
measure: Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively
timeFrame: Pre-operative and day 3 post-operatively
measure: Change From Baseline in Hematocrit (Hct) at Postoperative Day 1
timeFrame: Pre-operative and day 1 post-operatively
measure: Change From Baseline in Hematocrit (Hct) at Postoperative Day 2
timeFrame: Pre-operative and day 2 post-operatively
measure: Change From Baseline in Hematocrit (Hct) at Postoperative Day 3
timeFrame: Pre-operative and day 3 post-operatively
measure: Total Tourniquet Time
timeFrame: Intra-operatively (on day of surgery = Day 0)
measure: Amount of FLOSEAL Applied
timeFrame: Intra-operatively (Day 0)
measure: Duration of Surgery
timeFrame: Time from first incision to complete wound closure (Day 0)
measure: Transfusion Requirements - Packed Red Blood Cells
timeFrame: Intra-operatively (Day 0) thru Postoperative Day 3
measure: Total Drain Output at Day 1 Post-operatively
timeFrame: 1 day post-operatively
measure: Pain Management - Number of Days When Pain Medication Was Used
timeFrame: Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6
measure: Visual Analogue Scale (VAS) Pain Scores
timeFrame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6
measure: Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3
timeFrame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3
measure: Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1
timeFrame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1
measure: Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2
timeFrame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2
measure: Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6
timeFrame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6
measure: Western Ontario and McMaster Universities (WOMAC) Function Index Scores
timeFrame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
measure: Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
timeFrame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
measure: Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
timeFrame: Preoperative, and Postoperative Weeks 1, 2, and 6
measure: Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
timeFrame: Baseline and Postoperative Weeks 1, 2, and 6
measure: Length of Hospital Stay
timeFrame: From the day of hospitalization to the day of discharge
measure: Proportion of Participants With Transfusion Requirements
timeFrame: Intra-operative
measure: Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)
timeFrame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
measure: Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery
timeFrame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
timeFrame: 60 days
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
timeFrame: 60 days
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
timeFrame: 60 days
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
timeFrame: 60 days
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
timeFrame: 60 days
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
timeFrame: 60 days
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
timeFrame: 60 days
measure: Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
timeFrame: 60 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Orthopedic Center
state: California
city: Redwood City
country: United States
facility: Stanford Orthopedics
state: California
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants, PC
state: Colorado
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: DeLand
country: United States
facility: Florida Research Associates, LLC
state: Florida
city: Ft. Lauderdale
country: United States
facility: Shrock Orthopedic Research, LLC
state: Florida
city: Tamarac
country: United States
facility: Phoenix Clinical Research, LLC
state: Florida
city: Mooresville
country: United States
facility: Joint Replacement Surgeons of Indiana Foundations
state: Indiana
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Philadelphia
country: United States
facility: The Rothman Institute, Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Austin,
country: United States
facility: Hill Country Clinical Research, Inc.
state: Texas
Study officials:
affiliation: Baxter Innovations GmbH
name: Ildiko Szabo, MD, MBA
role: STUDY_DIRECTOR
References: