Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxter Healthcare Corporation
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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:
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
Clareo Health | Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
