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

December 20, 2016 updated by: David C. Ring, MD, Massachusetts General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with Mallet Finger
All enrolled patients
Other: PROMIS Upper Extremity
Other: Likert Pain Scale
Other: Mallet Finger Extensor Lag Measurement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (ESTIMATE)

August 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2014P001041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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