Navigator vs Standard Needle Injection for Hip

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cartiva, Inc.
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Lidocaine

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.