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Conservative Treatment of Mallet Finger Injury

Primary Purpose

Conservatively Treated Mallet Finger Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immobilization type for mallet injury
Sponsored by
Orthopaedic Specialty Group PC, Fairfield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conservatively Treated Mallet Finger Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopaedic Specialty Group PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment with Kinesiotape and Oval 8

Treatment with quick cast

Arm Description

Outcomes

Primary Outcome Measures

Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit

Secondary Outcome Measures

Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Brief Michigan Hand Outcome Questionnaire
Brief Michigan Hand Outcome Questionnaire
Satisfaction on a visual analog scale (0-10)
Satisfaction on a visual analog scale (0-10)
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Pain according to a numeric pain rating scale (0-10/10)
Pain according to a numeric pain rating scale (0-10/10)

Full Information

First Posted
March 30, 2021
Last Updated
April 19, 2022
Sponsor
Orthopaedic Specialty Group PC, Fairfield
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1. Study Identification

Unique Protocol Identification Number
NCT04830917
Brief Title
Conservative Treatment of Mallet Finger Injury
Official Title
Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopaedic Specialty Group PC, Fairfield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conservatively Treated Mallet Finger Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Kinesiotape and Oval 8
Arm Type
Experimental
Arm Title
Treatment with quick cast
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Immobilization type for mallet injury
Intervention Description
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury
Primary Outcome Measure Information:
Title
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Time Frame
12 weeks from injury
Secondary Outcome Measure Information:
Title
Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit
Time Frame
6 months post injury
Title
Brief Michigan Hand Outcome Questionnaire
Time Frame
12 weeks from injury
Title
Brief Michigan Hand Outcome Questionnaire
Time Frame
6 months post injury
Title
Satisfaction on a visual analog scale (0-10)
Time Frame
12 weeks from injury
Title
Satisfaction on a visual analog scale (0-10)
Time Frame
6 months post injury
Title
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Time Frame
12 week post injury
Title
Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit
Time Frame
6 months post injury
Title
Pain according to a numeric pain rating scale (0-10/10)
Time Frame
12 weeks after injury
Title
Pain according to a numeric pain rating scale (0-10/10)
Time Frame
6 months post injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Orthopaedic Specialty Group PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06825
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Conservative Treatment of Mallet Finger Injury

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