Total Hip ReplacementPUSHNCT04219098
Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)
A study testing Butterfly IQ in people with Total Hip Replacement and Arthroplasty, run by Anne Arundel Health System Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Hip Replacement, Arthroplasty
- What is being tested?
- Butterfly IQ
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following specific criteria will be considered for participation in the study:
- Subject is between 18-80 years of age.
- Subject is a suitable candidate for total hip replacement.
- Subject scheduled for surgery with the Butterfly IQ trained PA providing surgical assistance
- 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
- 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.
- Subject must be comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
Who cannot join
- Subjects will be excluded from participation in the study if they meet any of the following criteria:
- Subject is a woman who is pregnant or lactating
- Subject from the vulnerable groups: prisoners, adults unable to consent, children, non-English speaking, illiterate, and/or visually impaired)
- Subject who is not comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
- Subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial
- Subject has contraindications for any of the following: Ropivicaine, Epinephrine or Methylene Blue
Show all 9Show fewer
- Previous hip surgery
- History of infection in hip
- Morbid obesity defined as BMI>40
Trial locations and contacts
1 site in 1 country.
United States1 site
Anne Arundel Medical Center
Annapolis, Maryland, 21401
About this study
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.
Read the 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
- Conditions
- Total Hip Replacement, Arthroplasty
- Being tested
- Butterfly IQ, Standard of Care
- Keywords
- THA, THR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly IQProcedure or surgery
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.
Standard of CareOther
The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Butterfly IQ utilized to inject 10cc prior to surgery the remainder after incision Receives: Procedure: Butterfly IQ |
| Control | Active comparator | Entire injection will be given after initial incision is made. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Patient Reported Outcome Measure Information System (PROMIS) pain rating 0(no pain)- 5 (most pain)
Measured: Surgery
Secondary outcomes (1)
Blood Loss
Evaluate blood loss as determined by relative change in HCT preoperatively and on the first post-operative day.
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Feb 2020
- Primary completion30 Jul 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed to be prospective randomized (1:1) controlled independent trial.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Arundel Health System Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul King, Anne Arundel Health System Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219098
- Sponsor's protocol ID
- Designer [1544619
- Acronym
- PUSH
- Status last verified
- Aug 2024
- First submitted
- 30 Dec 2019
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Preoperative UltraSound Guided Hip Injections for Total Hip Arthroplasty (PUSH)
- ClinicalTrials.gov ID
- NCT04219098
- Acronym / sponsor ID
- PUSH / Designer [1544619
- Conditions
- Total Hip Replacement, Arthroplasty
- Keywords
- THA, THR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Anne Arundel Health System Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- This study is designed to be prospective randomized (1:1) controlled independent trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Butterfly IQButterfly IQ utilized to inject 10cc prior to surgery the remainder after incision |
| Control | Active comparator | Other: Standard of CareEntire injection will be given after initial incision is made. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects meeting all of the following specific criteria will be considered for participation in the study:
- Subject is between 18-80 years of age.
- Subject is a suitable candidate for total hip replacement.
- Subject scheduled for surgery with the Butterfly IQ trained PA providing surgical assistance
- 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
Key exclusion criteria (9 listed)
- Subjects will be excluded from participation in the study if they meet any of the following criteria:
- Subject is a woman who is pregnant or lactating
- Subject from the vulnerable groups: prisoners, adults unable to consent, children, non-English speaking, illiterate, and/or visually impaired)
- Subject who is not comfortable with speaking, reading, and understanding questions in English and providing an appropriate response.
- Subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butterfly IQ10ml 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. | Procedure or surgery | Treatment |
| Standard of CareThe entire volume will be injected into the periarticular tissues after prosthesis implantation before closure. | Other | Control |
Primary outcome
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)
1 secondary outcome
Blood Loss
Time frame: Postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly IQ in people with Total Hip Replacement and Arthroplasty, run by Anne Arundel Health System Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.