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

Not Applicable

Completed

• Conditions: Total Hip Replacement; Arthroplasty

• Registration Number: NCT04219098
• Lead Sponsor: Anne Arundel Health System Research Institute

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

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2020-02-01
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy	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 Outcome Measures

Name	Time	Method
Blood Loss	Postoperative day 1	Evaluate blood loss as determined by relative change in HCT preoperatively and on the first post-operative day.

Trial Locations

Locations (1)

Anne Arundel Medical Center; 🇺🇸 Annapolis, Maryland, United States