Navigator vs Standard Needle Injection for Hip

Cartiva

Status and phase: Completed; Phase 2

Conditions: Hip Pain Etiology Unknown

Treatments: Drug: Lidocaine; Drug: Celestone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066844

PTC-0369

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Standard Manual Needle Injection

Active Comparator group

Description:

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

Treatment:

Drug: Celestone

Drug: Lidocaine

Navigator Injection

Experimental group

Description:

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

Treatment:

Drug: Celestone

Drug: Lidocaine