Navigator vs Standard Needle Injection for Hip

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Carticept Medical, Inc
Sponsor:
Information provided by (Responsible Party):
Carticept Medical, Inc
ClinicalTrials.gov Identifier:
NCT02066844
First received: February 17, 2014
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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
Drug: 2cc of Celestone and 5cc of Lidocaine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Carticept Medical, Inc:

Primary Outcome Measures:
  • Injection Pain as measured by VAS for both treatment groups [ Time Frame: From 1 week to 12 weeks post-injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Patient Satisfaction [ Time Frame: From 1 week to 12 weeks post-injection ] [ Designated as safety issue: No ]
  • Drug Preparation Time [ Time Frame: From 1 week to 12 weeks post-injection ] [ Designated as safety issue: No ]
  • Hip Pain and Function [ Time Frame: From 1 week to 12 weeks post-injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2014
Estimated Study Completion Date: August 2014
Estimated 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: 2cc of Celestone and 5cc of Lidocaine
Experimental: Navigator Injection
2cc of Celestone and 5cc of Lidocaine will be administered using the Navigator by the nurse or surgeon
Drug: 2cc of Celestone and 5cc of Lidocaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066844

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Kaili Pecorella    585-341-9305      
Sponsors and Collaborators
Carticept Medical, Inc
Investigators
Principal Investigator: Brian Giordano, MD University of Rochester
  More Information

No publications provided

Responsible Party: Carticept Medical, Inc
ClinicalTrials.gov Identifier: NCT02066844     History of Changes
Other Study ID Numbers: PTC-0369
Study First Received: February 17, 2014
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Carticept Medical, Inc:
Hip Pain
Hip Injection
Hip Fracture
Hip Bursitis
Hip Arthritis
Hip Sciatica

Additional relevant MeSH terms:
Lidocaine
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014