Navigator vs Standard Needle Injection for Hip

Phase 2

Completed

• Conditions: Hip Pain Etiology Unknown
• Interventions: Drug: Celestone; Drug: Lidocaine

• Registration Number: NCT02066844
• Lead Sponsor: Cartiva, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-20
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Manual Needle Injection	Celestone	2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon
Standard Manual Needle Injection	Lidocaine	2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon
Navigator Injection	Celestone	2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon
Navigator Injection	Lidocaine	2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon

Primary Outcome Measures

Name	Time	Method
Injection Pain as measured by VAS for both treatment groups	From 1 week to 12 weeks post-injection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States