Navigator vs Standard Needle Injection for Hip
Information source: Cartiva, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Pain
Intervention: 2cc of Celestone and 5cc of Lidocaine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Cartiva, Inc. Official(s) and/or principal investigator(s): Brian Giordano, MD, Principal Investigator, Affiliation: University of Rochester
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.
Clinical Details
Official title: Phase II Study of Navigator vs Standard Needle Injection for Hip
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Injection Pain as measured by VAS for both treatment groups
Secondary outcome: Global Patient SatisfactionDrug Preparation Time Hip Pain and Function
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of Rochester, Rochester, New York 14642, United States; Recruiting Kaili Pecorella, Phone: 585-341-9305
Additional Information
Starting date: February 2014
Last updated: February 19, 2014
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