Study Comparing One Versus Two Cortisone Injections for T... | NCT00951236

Studies
Study Comparing One Versus Two Cortisone Injections for Trigger Finger

NCT00951236

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Feb 12, 2014Estimated

Enrollment

392Estimated

Phase

Not Applicable

Conditions

Stenosing Tenosynovitis
Trigger Finger

Interventions

One cortisone injection
Two cortisone Injections

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 31, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2014

Last Update Posted Date

Feb 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause discomfort and disability. Many physicians choose to locally inject cortisone into the infected finger although there is no current consensus as to how many injections are needed to achieve maximum relief. This study will be a prospective, randomized study to compare one versus two injections for the treatment of trigger finger.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

392Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One injection	Active Comparator		Drug: One cortisone injection
Two Injections	Active Comparator		Drug: Two cortisone Injections

Interventions

Name	Type	Description	Arm Group Labels	Other Names
One cortisone injection	Drug	Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms	One injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection

Secondary Outcomes

Measure	Description	Time Frame
To evaluate treatment response among diabetic patients
To evaluate treatment response between thumbs and fingers
To evaluate treatment response between nodular versus diffuse tenosynovitis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is greater than 18 years of age, presenting with stenosing tenosynovitis.
Subject is willing and able to provide informed consent.

Exclusion Criteria:

Patients who have previously undergone surgery for the treatment of trigger finger.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charles Leinberry, MD	Contact	267-339-3677		charlie.leinberry@rothmaninstitute.com
Tiffany Morrison, MS	Contact	267-339-7818		tiffany.morrison@rothmaninstitute.com

Overall Officials

Name	Affiliation	Role
Charles Leinberry, MD	Rothman Institute	Principal Investigator
Pedro Beredjiklian, MD	Rothman Institute	Principal Investigator
Emran Sheikh, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rothman Institute: Egg Harbor Township Location	Recruiting	Egg Harbor	New Jersey	08234	United States

Condition Browse Module

MeSH Terms

ID	Term
D053682	Tendon Entrapment
D052582	Trigger Finger Disorder

Ancestor Terms

ID	Term
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided