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Two Treatment for a Mallet Finger of Tendinous Origin

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ClinicalTrials.gov Identifier: NCT03899363
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

Brief Summary:

A randomized clinical trial, with patients treated either by a custom thermoplastic orthosis or by the Kirschner wire with the distal interphalangeal (DIP) joint extended.

Evaluating the treatment efficacy of the operation management compared with a conventional orthosis.


Condition or disease Intervention/treatment Phase
Mallet Finger Procedure: custom thermoplastic orthosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Trial of Two Treatment for a Mallet Finger of Tendinous Origin
Estimated Study Start Date : March 25, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: surgery Procedure: custom thermoplastic orthosis
extended the DIP by a custom thermoplastic orthosis or the Kirschner wire through the joint
Other Name: Kirschner wire

Active Comparator: custom thermoplastic orthosis Procedure: custom thermoplastic orthosis
extended the DIP by a custom thermoplastic orthosis or the Kirschner wire through the joint
Other Name: Kirschner wire




Primary Outcome Measures :
  1. Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed [ Time Frame: The first visit(Enrolled and completed treatment), 8 weeks after first visit(two weeks after 6 weeks fixation), 16 weeks(4 weeks after six weeks Rehabilitation) ]

    Use a Protractor to measure the maximum degree of active flexion of the DIP joint at the first visit and at the end treatment; Use a Protractor to measure the maximum degree of active extension of the DIP joint at the start of immobilization and end of treatment.

    (If the maximum degree of active flexion of two time periods are 40° and 40°,respectively; the maximum degree of active extension of two time periods are 20° and -10°,respectively. We could get the range of motion of the DIP joint of two time periods are 20°~40° and -10°~40°,respectively. The maximum extension angle increased by 30 degrees).To assess whether there was a statistical difference in ROM changes between the two groups before and after treatment.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of a mallet finger, with or without fracture;
  • Age≥18 years

Exclusion Criteria:

  • Open lesions
  • Mallet fractures with subluxation of the DIP
  • Delays in treatment >2 weeks
  • DM
  • RA

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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03899363     History of Changes
Other Study ID Numbers: SAHoWMU-CR2018-08-417
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No