Phase 3
N=52
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Osteoarthritis · Intraoperative Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01656759 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Primary--Percent Change of Pre- to Post-Operative Hemoglobin — 20.1; 22.5 Percent Change — p=0.2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Evicel Fibrin Spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary--Percent Change of Pre- to Post-Operative Hemoglobin |
20.1; 22.5 | 0.2 |
| PRIMARY Total Blood Loss |
605; 621 | 0.9 |
| SECONDARY Total Transfusions |
3; 3 | — |
| SECONDARY Postoperative Blood Loss |
543; 555 | 0.9 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients must be male or female of any race
- Ages 18-80 years old
- Patients must be undergoing an elective, primary knee arthroplasty performed by the principal investigator
Exclusion Criteria
- Allergy or intolerance to the study materials
- Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
- History of previous surgeries on the affected joint including previous arthroscopy (open surgeries)
- Women that are pregnant or may become pregnant
- Patient declines to participate
Data sourced from ClinicalTrials.gov (NCT01656759). 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.