Navigator vs Standard Needle Injection for Hip

January 27, 2016 updated by: Cartiva, Inc.

Phase II Study of Navigator vs Standard Needle Injection for Hip

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Manual Needle Injection
2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon
Drug: Celestone
2cc
Other Names:
  • Betamethasone Sodium Phosphate
Drug: Lidocaine
5cc
EXPERIMENTAL: Navigator Injection
2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon
Drug: Celestone
2cc
Other Names:
  • Betamethasone Sodium Phosphate
Drug: Lidocaine
5cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Injection Pain as measured by VAS for both treatment groups
Time Frame: From 1 week to 12 weeks post-injection
From 1 week to 12 weeks post-injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Patient Satisfaction
Time Frame: From 1 week to 12 weeks post-injection
From 1 week to 12 weeks post-injection
Drug Preparation Time
Time Frame: From 1 week to 12 weeks post-injection
From 1 week to 12 weeks post-injection
Hip Pain and Function
Time Frame: From 1 week to 12 weeks post-injection
From 1 week to 12 weeks post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cartiva, Inc.

Investigators

  • Principal Investigator: Brian Giordano, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (ESTIMATE)

February 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTC-0369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Pain Etiology Unknown

Clinical Trials on Celestone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe