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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Butterfly IQ utilized to inject 10cc prior to surgery the remainder after incision |
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| Control | Active Comparator | Entire injection will be given after initial incision is made. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butterfly IQ | Procedure | 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. |
| 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 Patient Reported Outcome Measure Information System (PROMIS) pain rating 0(no pain)- 5 (most pain) | Surgery |
| 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 |
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Inclusion Criteria
Subjects meeting all of the following specific criteria will be considered for participation in the study:
Exclusion Criteria
Subjects will be excluded from participation in the study if they meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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This study is designed to be prospective randomized (1:1) controlled independent trial.
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Only the surgeon and PA will be aware of the randomization assignment
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| Standard of Care | Other | The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure. |
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