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Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty

NCT01027286 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2012-11-29

Study results available
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Summary

Vitagel® is an FDA approved class III medical device. It is a surgical hemostat, which has been shown to control bleeding during orthopaedic, cardiac, hepatic, and general surgical procedures. The product is a thrombin/collagen suspension which works in combination with the patient's own plasma to form a fibrin/collagen clot.

The present prospective, randomized controlled trial is designed to evaluate the efficacy of Vitagel® for reducing blood loss and pain in patients managed with unilateral total knee arthroplasty (TKA). It is hypothesized that the use of Vitagel® may lead to less blood filled knees, and thus to a greater improvement in postoperative pain scores when compared to the control group. The two arms of the study will include:

1. experimental group in which Vitagel® is used unilateral TKA
2. control group representing our current standard of care (no Vitagel®)

A comparison of the functional and clinical results between these two groups will be conducted using several outcome measures including the KOOS, SF-12 version2 and pain scores through the previously IRB approved OrthoMidas registry. The primary variable of interest is blood loss, based on hemoglobin drop during the postoperative hospital stay. Of secondary interest will be; 1) pain levels in the PACU, 2) pain scores for all postoperative days, 3) average pain for the entire hospital stay, 4) length of stay, 5) patient satisfaction at discharge, 4 weeks postoperative, and 12 weeks postoperative, and 6) functional scores at 4 and 12 weeks postoperative.

Conditions

Interventions

DEVICE

Vitagel

Vitagel applied just prior to closure during primary total knee arthroplasty

Sponsors & Collaborators

  • Orthovita d/b/a Stryker

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Wael K Barsoum, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-04-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027286 on ClinicalTrials.gov