At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 73 enrolled
Drug / intervention
Evicel Fibrin Spraydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Evicel Fibrin Spray for Osteoarthritis and Intraoperative Bleeding. Completed, enrolled 73 participants across 1 site.
Detailed Summary
Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Intraoperative Bleeding
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedAug 2012
Primary CompletionDec 2014
Study CompletionAug 2015
TodayJul 2026
First PostedAug 3, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2014
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.9 years ago
Interventions
Evicel Fibrin Spraydrug
10cc syringe dose, once at the end of TKA