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A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty

Study:

A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty

Rationale:

n/a

Purpose:

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 Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Arthritis Device: Vitagel Phase 4

Verified by The Cleveland Clinic August, 2012

Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT01285024

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Wael K Barsoum, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.