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The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Manual Needle Injection | Active Comparator | 2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon |
|
| Navigator Injection | Experimental | 2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celestone | Drug | 2cc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Injection Pain as measured by VAS for both treatment groups | From 1 week to 12 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Global Patient Satisfaction | From 1 week to 12 weeks post-injection | |
| Drug Preparation Time | From 1 week to 12 weeks post-injection | |
| Hip Pain and Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Giordano, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 30, 2017 | |
| Reset | Mar 16, 2017 | |
| Release | Jul 31, 2017 | |
| Reset | Aug 30, 2017 | |
| Release | Jan 23, 2018 | |
| Reset | Feb 20, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2017 | Mar 16, 2017 | |||
| Jul 31, 2017 |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| C028994 | betamethasone sodium phosphate |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Lidocaine | Drug | 5cc |
|
| From 1 week to 12 weeks post-injection |
| Aug 30, 2017 |
| Jan 23, 2018 | Feb 20, 2018 |
| D007869 |
| Leg Injuries |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |