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

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.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty; Total Hip Replacement
• Intervention / Treatment: Procedure: Butterfly IQ; Other: Standard of Care

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Subjects meeting all of the following specific criteria will be considered for participation in the study:

1. Subject is between 18-80 years of age.
2. Subject is a suitable candidate for total hip replacement.
3. Subject scheduled for surgery with the Butterfly IQ trained PA providing surgical assistance
4. Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to AAHS RI
5. Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
6. Subject must be comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.

Exclusion Criteria

Subjects will be excluded from participation in the study if they meet any of the following criteria:

1. Subject is a woman who is pregnant or lactating
2. Subject from the vulnerable groups: prisoners, adults unable to consent, children, non-English speaking, illiterate, and/or visually impaired)
3. Subject who is not comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
4. Subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial
5. Subject has contraindications for any of the following: Ropivicaine, Epinephrine or Methylene Blue
6. Previous hip surgery
7. History of infection in hip
8. Morbid obesity defined as BMI>40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Butterfly IQ utilized to inject 10cc prior to surgery the remainder after incision	Procedure: Butterfly IQ; 10ml of solution with .5cc (or one drop) sterile methylene blue will be injected intra-articularly under ultrasound guidance after a sterile prep. The remaining 20ml will be injected into the periarticular tissues after prosthesis implantation before closure.
Active Comparator: Control; Entire injection will be given after initial incision is made.	Other: Standard of Care; The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	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 PROMIS pain score	Surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anne Arundel Health System Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: THA; THR
• Other Study ID Numbers: Designer [1544619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No