Navigator vs Standard Needle Injection for Hip

NCT ID: NCT02066844

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-08-31

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.

Conditions

Hip Pain Etiology Unknown

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Manual Needle Injection

2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon

Group Type: ACTIVE_COMPARATOR

Celestone

Intervention Type: DRUG

2cc

Lidocaine

Intervention Type: DRUG

5cc

Navigator Injection

2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon

Group Type: EXPERIMENTAL

Celestone

Intervention Type: DRUG

2cc

Lidocaine

Intervention Type: DRUG

5cc

Interventions

Celestone

2cc

Intervention Type: DRUG

Lidocaine

5cc

Intervention Type: DRUG

Other Intervention Names

Betamethasone Sodium Phosphate

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cartiva, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Giordano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

PTC-0369

Identifier Type: -

Identifier Source: org_study_id