Status:
COMPLETED
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
Brief Summary
Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfus...
Detailed Description
No additional data desired
Eligibility Criteria
Inclusion
- \- Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty
Exclusion
- Known allergies to human blood products.
- History of bleeding disorders.
- Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.
- Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)
- Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01235715
Start Date
September 1 2010
End Date
September 1 2012
Last Update
October 29 2013
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021