NCT04830917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

March 30, 2021

Last Update Submit

April 19, 2022

Conditions

Conservatively Treated Mallet Finger Injury

Outcome Measures

Primary Outcomes (1)

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

    12 weeks from injury

Secondary Outcomes (9)

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

    6 months post injury

  • Brief Michigan Hand Outcome Questionnaire

    12 weeks from injury

  • Brief Michigan Hand Outcome Questionnaire

    6 months post injury

  • Satisfaction on a visual analog scale (0-10)

    12 weeks from injury

  • Satisfaction on a visual analog scale (0-10)

    6 months post injury

  • +4 more secondary outcomes

Study Arms (2)

Treatment with Kinesiotape and Oval 8

EXPERIMENTAL
Other: Immobilization type for mallet injury

Treatment with quick cast

EXPERIMENTAL
Other: Immobilization type for mallet injury

Interventions

Immobilization type for mallet injuryOTHER

Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury

Treatment with Kinesiotape and Oval 8Treatment with quick cast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous injury to the involved digit impacting ROM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Specialty Group PC

Fairfield, Connecticut, 06825, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hand therapist/occupational therapist

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 5, 2021

Study Start

April 24, 2017

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

US(1)