Phase 4
N=118
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
Knee Replacement Surgery · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01410240 ↗Enrolled (actual)
118
Serious AEs
8.5%
Results posted
Jun 2014
Primary outcome: Primary: Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively — -3.73; -3.70 g/dL — p=0.453
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Standard of Care (Procedure); FLOSEAL Hemostatic Matrix + Standard of care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively |
-3.73; -3.70 | 0.453 |
| PRIMARY Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP) |
0.00; 0.00; 0.02; 0.00 | — |
| SECONDARY Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively |
-3.02; -3.15 | 0.708 |
| SECONDARY Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively |
-3.81; -3.84 | 0.527 |
| SECONDARY Change From Baseline in Hematocrit (Hct) at Postoperative Day 1 |
-9.0; -8.8 | 0.561 |
| SECONDARY Change From Baseline in Hematocrit (Hct) at Postoperative Day 2 |
-11.2; -10.6 | 0.356 |
| SECONDARY Change From Baseline in Hematocrit (Hct) at Postoperative Day 3 |
-11.1; -11.0 | 0.533 |
| SECONDARY Total Tourniquet Time |
49.2; 47.3 | 0.734 |
| SECONDARY Amount of FLOSEAL Applied |
18.1 | — |
| SECONDARY Duration of Surgery |
74.5; 76.9 | — |
| SECONDARY Transfusion Requirements - Packed Red Blood Cells |
484.0; 403.3 | 0.314 |
| SECONDARY Total Drain Output at Day 1 Post-operatively |
839.6; 647.3 | 0.063 |
| SECONDARY Pain Management - Number of Days When Pain Medication Was Used |
28.7; 31.9; 25.1; 30.3 | — |
| SECONDARY Visual Analogue Scale (VAS) Pain Scores |
4.9; 4.4; 3.2; 4.1; 4.4; 4.8 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3 |
-1.6; -0.1 | 0.058 |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1 |
-0.4; 0.4 | 0.421 |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2 |
-1.8; -0.5 | 0.161 |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6 |
-3.5; -2.1 | 0.016 sig |
| SECONDARY Western Ontario and McMaster Universities (WOMAC) Function Index Scores |
26.8; 27.6; 11.9; 11.6; 91.3; 92.3 | — |
| SECONDARY Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores |
-7.3; -5.1; -1.7; -0.1; 4.7; 17.0 | 0.534 |
| SECONDARY Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6 |
24.9; 25.8; 32.9; 33.5; 35.5; 36.2 | — |
| SECONDARY Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6 |
-2.1; -2.7; -8.0; -6.6; -2.3; -3.4 | 0.962 |
| SECONDARY Length of Hospital Stay |
3.52; 3.38 | 0.052 |
| SECONDARY Proportion of Participants With Transfusion Requirements |
0.25; 0.19 | — |
| SECONDARY Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage) |
0.03; 0.06 | — |
| SECONDARY Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery |
0.26; 0.36 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist |
24; 22; 42; 47; 43; 48 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance |
1; 2; 1; 1; 0; 1 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker |
17; 20; 39; 41; 38; 46 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane |
1; 0; 0; 0; 2; 0 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair |
0; 0; 1; 1; 1; 1 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair) |
0; 0; 1; 0; 3; 0 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed |
23; 27; 4; 5; 3; 0 | — |
| SECONDARY Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk |
2; 2; 13; 12; 13; 13 | — |
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:
- 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
Data sourced from ClinicalTrials.gov (NCT01410240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.