Surgical Treatment of Adult Trigger Finger | NCT02196233

Studies
Surgical Treatment of Adult Trigger Finger

NCT02196233

Sponsor

University of Utah

Status

Completed

Last Update Posted

Aug 20, 2019Actual

Enrollment

86Actual

Phase

Not provided

Conditions

Trigger Finger

Interventions

Not provided

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jul 2019Actual

Completion Date

Jul 2019Actual

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 18, 2014

First Posted Date

Jul 21, 2014Estimated

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

Aug 16, 2019

Last Update Posted Date

Aug 20, 2019Actual

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 is a condition commonly treated with surgical intervention, yet no specific incision type has been associated with improved or worsened scar quality or outcome. Therefore, the investigators objective is to determine if the incision type may affect the results of operative treatment of trigger finger. Therefore, the goals of this study are as follows:

Primary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release with scar quality and patient satisfaction via a validated scar evaluation scale.

Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for trigger finger release to patient outcome via a validated upper extremity outcome score.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trigger Finger Release with Scar Quality and Patient Satisfaction via a Validated Scar Evaluation Scale		1 Year Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Trigger Finger Release to Patient Outcome via a Validated Upper Extremity Outcome Score		1 Year Follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients over the age of 18 presenting to the four attending surgeons (Don Coleman, Douglas Hutchinson, Andrew Tyser, Angela Wang) through either the University of Utah Orthopaedic Center or the Veteran Affairs Hospital will be evaluated for possible inclusion into the study
Patients who fail conservative treatment and elect to proceed with open surgical release of the A1 pulley will be offered the option of being included in the study.

Exclusion Criteria:

Patients aged less than 18, previous failed surgical A1 pulley release, and patients receiving their care outside of the University of Utah Hospital system or the Veteran Affairs Hospital
In addition, this study will evaluate trigger finger release; patients receiving treatment for trigger thumb will be excluded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

All patients over the age of 18 presenting to the four attending surgeons with Trigger Finger

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas Hutchinson	Orthopedic Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah		Salt Lake City	Utah	84108	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11476534	Background	Saldana MJ. Trigger digits: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):246-52. doi: 10.5435/00124635-200107000-00004.
16443118	Background	Ryzewicz M, Wolf JM. Trigger digits: principles, management, and complications. J Hand Surg Am. 2006 Jan;31(1):135-46. doi: 10.1016/j.jhsa.2005.10.013.

ID	Term
D053682	Tendon Entrapment
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases