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Clinical Trials/NCT04219098
NCT04219098
Completed
Not Applicable

Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)

Anne Arundel Health System Research Institute1 site in 1 country75 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Replacement
Sponsor
Anne Arundel Health System Research Institute
Enrollment
75
Locations
1
Primary Endpoint
Accuracy
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of the study is to assess the accuracy of Butterfly IQ ultrasound for intra-articular hip injections, and to see if an injection given intra-articular before incision provides any benefit in preemptive pain relief or blood loss reduction.

Detailed Description

This study is designed to be prospective randomized (1:1) controlled independent trial. Subjects are male and female, aged 18 and above, who are suitable candidates for either a unilateral (i.e. single) total hip replacement. Subjects that are scheduled with a single, extensively trained Physician Assistant assisting in their surgery will be exclusively included. This is single site study with projected enrollment of 150 subjects

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
August 30, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Anne Arundel Health System Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Paul King

Director of the Center for Joint Replacement

Anne Arundel Health System Research Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Accuracy

Time Frame: Surgery

Primary objective is to determine the accuracy of the Butterfly IQ portable app based ultrasound device used in intra-articular hip injections determined by patient reported pain ratings using the Patient Reported Outcome Measure Information System (PROMIS) pain rating 0(no pain)- 5 (most pain)

Secondary Outcomes

  • Blood Loss(Postoperative day 1)

Study Sites (1)

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