DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Satisfaction

Drug 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017