Hip Pain Etiology Unknown
Conditions
Keywords
Hip Pain, Hip Injection, Hip Fracture, Hip Bursitis, Hip Arthritis, Hip Sciatica
Brief summary
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.
Interventions
DRUGCelestone
2cc
DRUGLidocaine
5cc
Sponsors
Cartiva, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females, ≥18 years of age, of any race or ethnicity; * Capable of completing self-administered questionnaires; * Patients with suspected intra-articular hip pain who have failed conservative care (conservative care defined as a standard regimen of home or outpatient physical therapy, activity modification, trial of at least one NSAID) for at least 3 months; * Candidate for a hip injection; * Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the Institutional Review Board/Ethics Committee. * Subjects are able to understand and speak English
Exclusion criteria
* History of intra-articular injection within the last 3 months prior to the injection procedure; * Complex regional pain syndrome; * History of prior hip surgery; * History of substance abuse; * Known history of hypersensitivity to local anesthetics of the amide type; * Contraindicated for Celestone (betamethasone sodium phosphate); * Contraindicated for Lidocaine Hydrochloride; * Is a prisoner or ward of the state; * Are unable to meet the treatment and follow up protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Injection Pain as measured by VAS for both treatment groups | From 1 week to 12 weeks post-injection |
Secondary
| Measure | 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 | From 1 week to 12 weeks post-injection |
Countries
United States
Outcome results
None listed