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Treatment Group--Evicel Fibrin Spray for Osteoarthritis

Phase 2 & 3

Waitlist Available

Led By Brett R Levine, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operative to 1 month

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Osteoarthritis
Intraoperative Blood Loss

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operative to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative to 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary--Percent Change of Pre- to Post-Operative Hemoglobin

Total Blood Loss

Secondary study objectives

Postoperative Blood Loss

Total Transfusions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Control GroupActive Control1 Intervention

Control group. Will not receive the fibrin spray.

Group II: Treatment Group--Evicel Fibrin SprayActive Control1 Intervention

Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured.

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