Residual Extensor Lag Approximately 1 Month After Splint... | NCT02210676

Studies
Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger

NCT02210676

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Dec 22, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Patients Present With Mallet Finger

Interventions

PROMIS Upper Extremity
Likert Pain Scale
Mallet Finger Extensor Lag Measurement

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the investigator leaving the institution, the study was terminated

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Not provided

First Submitted Date

Aug 5, 2014

First Submission Date that Met QC Criteria

Aug 6, 2014

First Posted Date

Aug 7, 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

Dec 20, 2016

Last Update Posted Date

Dec 22, 2016Estimated

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

Aim:

The purpose of the study is to learn more about how a person recovers after treatment for mallet finger injury. The investigators want to identify the best outcome after mallet finger injury and how to improve treatment strategies.

Primary null hypothesis:

There are no statistically significant factors associated with extensor lag between 4 weeks and 4 months after immobilization is discontinued for a mallet finger among demographic, injury, and treatment factors.

Secondary null hypothesis:

There are no statistically significant factors associated with PROMIS upper extremity function between 4 weeks and 4 months after completion of immobilization for a mallet finger among demographic, psychological, injury, and treatment factors.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Mallet Finger	Experimental	All enrolled patients	Other: PROMIS Upper Extremity Other: Likert Pain Scale Other: Mallet Finger Extensor Lag Measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PROMIS Upper Extremity	Other		Patients with Mallet Finger
Likert Pain Scale

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mallet Finger Extensor Lag		Baseline
Mallet Finger Extensor Lag		4 weeks to 4 months after diagnosis

Secondary Outcomes

Measure	Description	Time Frame
Patient Reported Outcomes Measure Information System (PROMIS) Upper Extremity	A computerized assessment of upper extremity function	4 weeks to 4 months after diagnosis
Likert Pain Scale		4 weeks to 4 months after diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age and older
English fluency and literacy
Mallet finger fracture or non-fracture
Mallet finger subluxation or non-subluxation

Exclusion Criteria:

Pregnant Women

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

Not provided

Overall Officials

Name	Affiliation	Role
David Ring, MD PhD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States