NCT02066844

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

February 17, 2014

Last Update Submit

January 27, 2016

Conditions

Hip Pain Etiology Unknown

Keywords

Hip PainHip InjectionHip FractureHip BursitisHip ArthritisHip Sciatica

Outcome Measures

Primary Outcomes (1)

  • Injection Pain as measured by VAS for both treatment groups

    From 1 week to 12 weeks post-injection

Secondary Outcomes (3)

  • Global Patient Satisfaction

    From 1 week to 12 weeks post-injection

  • Drug Preparation Time

    From 1 week to 12 weeks post-injection

  • Hip Pain and Function

    From 1 week to 12 weeks post-injection

Study Arms (2)

Standard Manual Needle Injection

ACTIVE COMPARATOR

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

Drug: CelestoneDrug: Lidocaine

Navigator Injection

EXPERIMENTAL

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

Drug: CelestoneDrug: Lidocaine

Interventions

CelestoneDRUG

2cc

Also known as: Betamethasone Sodium Phosphate
Navigator InjectionStandard Manual Needle Injection
LidocaineDRUG

5cc

Navigator InjectionStandard Manual Needle Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Betamethasonebetamethasone sodium phosphateLidocaine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Brian Giordano, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 28, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)