Conservative Treatment of Mallet Finger Injury

April 19, 2022 updated by: Lori Algar, Orthopaedic Specialty Group PC, Fairfield

Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury

Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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
    • Connecticut
      • Fairfield, Connecticut, United States, 06825
        • Orthopaedic Specialty Group PC

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:

  • determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age

Exclusion Criteria:

  • previous injury to the involved digit impacting ROM

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Kinesiotape and Oval 8
Other: Immobilization type for mallet injury
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury
Experimental: Treatment with quick cast
Other: Immobilization type for mallet injury
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Time Frame: 12 weeks from injury
12 weeks from injury

Secondary Outcome Measures

Outcome Measure
Time Frame
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Time Frame: 6 months post injury
6 months post injury
Brief Michigan Hand Outcome Questionnaire
Time Frame: 12 weeks from injury
12 weeks from injury
Brief Michigan Hand Outcome Questionnaire
Time Frame: 6 months post injury
6 months post injury
Satisfaction on a visual analog scale (0-10)
Time Frame: 12 weeks from injury
12 weeks from injury
Satisfaction on a visual analog scale (0-10)
Time Frame: 6 months post injury
6 months post injury
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Time Frame: 12 week post injury
12 week post injury
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Time Frame: 6 months post injury
6 months post injury
Pain according to a numeric pain rating scale (0-10/10)
Time Frame: 12 weeks after injury
12 weeks after injury
Pain according to a numeric pain rating scale (0-10/10)
Time Frame: 6 months post injury
6 months post injury

Collaborators and Investigators

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

Sponsor

Orthopaedic Specialty Group PC, Fairfield

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 (Actual)

April 24, 2017

Primary Completion (Actual)

April 28, 2021

Study Completion (Actual)

April 28, 2021

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVMC 17-328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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