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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
University of Rochester
Rochester, New York, United States
Injection Pain as measured by VAS for both treatment groups
Time frame: From 1 week to 12 weeks post-injection
Global Patient Satisfaction
Time frame: From 1 week to 12 weeks post-injection
Drug Preparation Time
Time frame: From 1 week to 12 weeks post-injection
Hip Pain and Function
Time frame: From 1 week to 12 weeks post-injection
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