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Completed

NCT Number: NCT02066844

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celestone

Drug

2cc

Other names: Betamethasone Sodium Phosphate

Lidocaine

Drug

5cc

Primary outcomes

  1. Injection Pain as measured by VAS for both treatment groups

    Time frame: From 1 week to 12 weeks post-injection

Secondary outcomes

  1. Global Patient Satisfaction

    Time frame: From 1 week to 12 weeks post-injection

  2. Drug Preparation Time

    Time frame: From 1 week to 12 weeks post-injection

  3. Hip Pain and Function

    Time frame: From 1 week to 12 weeks post-injection

Sponsors and collaborators

Lead sponsor

Cartiva, Inc.

Industry

Registry information

Official study title

Phase II Study of Navigator vs Standard Needle Injection for Hip

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2014
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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