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Navigator vs Standard Needle Injection for Hip

This study has been completed.
Information provided by (Responsible Party):
Cartiva, Inc. Identifier:
First received: February 17, 2014
Last updated: January 27, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Hip Pain Etiology Unknown
Drug: Celestone
Drug: Lidocaine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Phase II Study of Navigator vs Standard Needle Injection for Hip

Resource links provided by NLM:

Further study details as provided by Cartiva, Inc.:

Primary Outcome Measures:
  • Injection Pain as measured by VAS for both treatment groups [ Time Frame: From 1 week to 12 weeks post-injection ]

Secondary Outcome Measures:
  • Global Patient Satisfaction [ Time Frame: From 1 week to 12 weeks post-injection ]
  • Drug Preparation Time [ Time Frame: From 1 week to 12 weeks post-injection ]
  • Hip Pain and Function [ Time Frame: From 1 week to 12 weeks post-injection ]

Enrollment: 40
Study Start Date: February 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Manual Needle Injection
2cc of Celestone and 5cc of Lidocaine will be administered by the nurse or surgeon
Drug: Celestone
Other Name: Betamethasone Sodium Phosphate
Drug: Lidocaine
Experimental: Navigator Injection
2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon
Drug: Celestone
Other Name: Betamethasone Sodium Phosphate
Drug: Lidocaine


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02066844

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
Cartiva, Inc.
Principal Investigator: Brian Giordano, MD University of Rochester
  More Information

Responsible Party: Cartiva, Inc. Identifier: NCT02066844     History of Changes
Other Study ID Numbers: PTC-0369
Study First Received: February 17, 2014
Last Updated: January 27, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Cartiva, Inc.:
Hip Pain
Hip Injection
Hip Fracture
Hip Bursitis
Hip Arthritis
Hip Sciatica

Additional relevant MeSH terms:
Betamethasone benzoate
Betamethasone Valerate
Betamethasone sodium phosphate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents processed this record on May 23, 2017