Arthroplasty, Total Hip Replacement
Conditions
Keywords
THA, THR
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
Interventions
PROCEDUREButterfly 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.
OTHERStandard of Care
The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.
Sponsors
Anne Arundel Health System Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Only the surgeon and PA will be aware of the randomization assignment
Intervention model description
This study is designed to be prospective randomized (1:1) controlled independent trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | Postoperative day 1 | Evaluate blood loss as determined by relative change in HCT preoperatively and on the first post-operative day. |
Countries
United States
Outcome results
None listed