CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Vitageldevice
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.

Search/NCT01285024
NCT01285024N/ACompleted
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A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty

The Cleveland Clinic·interventional·Posted Jan 27, 2011·Updated Apr 11, 2017

In Brief

A clinical study evaluating Vitagel for Arthritis. Completed, enrolled 109 participants across 1 site.

Detailed Summary

This is a prospective, randomized, controlled, single-center study to assess the effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects. Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or any other hemostatic agent except those that are standard during a primary THA. The study will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis
CountriesUnited States
CollaboratorsOrthovita d/b/a Stryker, Stryker Instruments

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2011
Enrollment StartDec 1, 2010
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.4 years ago

Interventions

Vitageldevice

Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.