NCT01410240已完成4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 12
- 主要终点
- Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care (SoC)
Active Comparator
SoC: conventional hemostatic techniques such as cautery and manual compression
干预措施: Standard of Care (Procedure)
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
干预措施: FLOSEAL Hemostatic Matrix + Standard of care (Drug)
结局指标
主要结局
Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
时间窗: Pre-operative and 2 days post-operatively
Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
时间窗: Throughout the study period, 1 year and 4 months
* 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
次要结局
- 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)
- Total Tourniquet Time(Intra-operatively (on day of surgery = Day 0))
- Amount of FLOSEAL Applied(Intra-operatively (Day 0))
- Duration of Surgery(Time from first incision to complete wound closure (Day 0))
- Transfusion Requirements - Packed Red Blood Cells(Intra-operatively (Day 0) thru Postoperative Day 3)
- Total Drain Output at Day 1 Post-operatively(1 day post-operatively)
- Pain Management - Number of Days When Pain Medication Was Used(Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6)
- Visual Analogue Scale (VAS) Pain Scores(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(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(Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1)
- Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed(60 days)
- Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2(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(Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6)
- Western Ontario and McMaster Universities (WOMAC) Function Index Scores(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(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(Preoperative, and Postoperative Weeks 1, 2, and 6)
- Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6(Baseline and Postoperative Weeks 1, 2, and 6)
- Length of Hospital Stay(From the day of hospitalization to the day of discharge)
- Proportion of Participants With Transfusion Requirements(Intra-operative)
- Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)(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(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(60 days)
- Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance(60 days)
- Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker(60 days)
- Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane(60 days)
- Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair(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)(60 days)
- Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk(60 days)
研究者
研究点 (12)
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