- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410240
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90042
- Cedars-Sinai Orthopedic Center
-
Redwood City, California, United States, 94063
- Stanford Orthopedics
-
-
Colorado
-
Englewood, Colorado, United States, 80110
- Colorado Orthopedic Consultants, PC
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- George Washington University Medical Faculty Associates
-
-
Florida
-
DeLand, Florida, United States, 32720
- Florida Research Associates, LLC
-
Ft. Lauderdale, Florida, United States, 33316
- Shrock Orthopedic Research, LLC
-
Tamarac, Florida, United States, 33321
- Phoenix Clinical Research, LLC
-
-
Indiana
-
Mooresville, Indiana, United States, 46158
- Joint Replacement Surgeons of Indiana Foundations
-
-
New Jersey
-
Egg Harbor Township, New Jersey, United States, 08234-5500
- Rothman Institute
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Temple University
-
Philadelphia, Pennsylvania, United States, 19107
- The Rothman Institute, Philadelphia
-
-
Texas
-
Austin,, Texas, United States, 78759
- Hill Country Clinical Research, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care (SoC)
SoC: conventional hemostatic techniques such as cautery and manual compression
|
Conventional hemostatic techniques, such as cautery and manual compression, will be used.
|
Experimental: FLOSEAL + Standard of Care (SoC)
FLOSEAL: consists of bovine-derived gelatin granules and a human plasma-derived thrombin component. SoC: conventional hemostatic techniques such as cautery and manual compression |
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
Time Frame: Pre-operative and 2 days post-operatively
|
Pre-operative and 2 days post-operatively
|
|
Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
Time Frame: Throughout the study period, 1 year and 4 months
|
|
Throughout the study period, 1 year and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively
Time Frame: Pre-operative and day 1 post-operatively
|
Pre-operative and day 1 post-operatively
|
|
Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively
Time Frame: Pre-operative and day 3 post-operatively
|
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.
|
Pre-operative and day 3 post-operatively
|
Change From Baseline in Hematocrit (Hct) at Postoperative Day 1
Time Frame: Pre-operative and day 1 post-operatively
|
Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.
|
Pre-operative and day 1 post-operatively
|
Change From Baseline in Hematocrit (Hct) at Postoperative Day 2
Time Frame: Pre-operative and day 2 post-operatively
|
Pre-operative and day 2 post-operatively
|
|
Change From Baseline in Hematocrit (Hct) at Postoperative Day 3
Time Frame: Pre-operative and day 3 post-operatively
|
Pre-operative and day 3 post-operatively
|
|
Total Tourniquet Time
Time Frame: Intra-operatively (on day of surgery = Day 0)
|
Measured from the time point of the tourniquet inflation to deflation using the same watch/clock
|
Intra-operatively (on day of surgery = Day 0)
|
Amount of FLOSEAL Applied
Time Frame: Intra-operatively (Day 0)
|
Intra-operatively (Day 0)
|
|
Duration of Surgery
Time Frame: Time from first incision to complete wound closure (Day 0)
|
Time from first incision to complete wound closure (Day 0)
|
|
Transfusion Requirements - Packed Red Blood Cells
Time Frame: Intra-operatively (Day 0) thru Postoperative Day 3
|
Intra-operatively (Day 0) thru Postoperative Day 3
|
|
Total Drain Output at Day 1 Post-operatively
Time Frame: 1 day post-operatively
|
1 day post-operatively
|
|
Pain Management - Number of Days When Pain Medication Was Used
Time Frame: Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6
|
Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis. While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary. |
Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6
|
Visual Analogue Scale (VAS) Pain Scores
Time Frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6
|
Participant rated assessment of the level of pain they are experiencing with their operated knee.
The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain).
For the pain scale, a higher score indicates worse pain.
|
Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3
Time Frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3
|
Participant rated assessment of the level of pain they are experiencing with their operated knee.
The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain).
For the pain scale, a higher score indicates worse pain.
|
Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1
Time Frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1
|
Participant rated assessment of the level of pain they are experiencing with their operated knee.
The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain).
For the pain scale, a higher score indicates worse pain.
|
Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2
Time Frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2
|
Participant rated assessment of the level of pain they are experiencing with their operated knee.
The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain).
For the pain scale, a higher score indicates worse pain.
|
Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2
|
Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6
Time Frame: Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6
|
Participant rated assessment of the level of pain they are experiencing with their operated knee.
The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain).
For the pain scale, a higher score indicates worse pain.
|
Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6
|
Western Ontario and McMaster Universities (WOMAC) Function Index Scores
Time Frame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
|
A well-validated scale to reflect problems in people with lower limb issues.
Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues). Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues) Postoperative (Postop) |
Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
|
Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores
Time Frame: Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
|
A well-validated scale to reflect problems in people with lower limb issues.
Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues). Postoperative (Postop) |
Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6
|
Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6
Time Frame: Preoperative, and Postoperative Weeks 1, 2, and 6
|
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS).
Scores range 0-100, higher scores represent better health.
There is no total overall score; scoring is done for subscores and summary scores.
Scores were included where data was available.
|
Preoperative, and Postoperative Weeks 1, 2, and 6
|
Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6
Time Frame: Baseline and Postoperative Weeks 1, 2, and 6
|
Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available. Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) - (Baseline Scores). |
Baseline and Postoperative Weeks 1, 2, and 6
|
Length of Hospital Stay
Time Frame: From the day of hospitalization to the day of discharge
|
From the day of hospitalization to the day of discharge
|
|
Proportion of Participants With Transfusion Requirements
Time Frame: Intra-operative
|
Intra-operative
|
|
Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)
Time Frame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
|
Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
|
|
Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery
Time Frame: Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
|
Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6
|
|
Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk
Time Frame: 60 days
|
The number of participants responding affirmative in their rehabilitation diaries for each day
|
60 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ildiko Szabo, MD, MBA, Baxter Innovations GmbH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 611001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Standard of Care
-
brett rasmussenCompleted
-
Indonesia UniversityCompletedCovid19 | AcupunctureIndonesia
-
Johns Hopkins UniversityRecruitingCompartment Syndrome of Leg | Extracorporeal Membrane Oxygenation Complication | Limb Ischemia, Critical | Limb IschemiaUnited States
-
Aventusoft, LLC.National Heart, Lung, and Blood Institute (NHLBI); Cleveland Clinic FloridaRecruitingHeart Failure (HF)United States
-
Vascular Biogenics Ltd. operating as VBL TherapeuticsCompletedSevere COVID-19Israel
-
Ruijin HospitalRecruitingCOVID-19 PneumoniaChina
-
Institut Claudius RegaudCompletedMETASTATIC CANCERFrance
-
Ziv HospitalNot yet recruiting
-
Hofseth Biocare ASAKGK Science Inc.CompletedCovid-19 | COVIDCanada, Brazil, Hungary, Mexico, Serbia
-
City University of New York, School of Public HealthNew York State Psychiatric Institute; University of KwaZulu; International Initiative... and other collaboratorsCompleted