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Clinical Trials/NCT03899363
NCT03899363
Unknown
N/A

A Prospective, Randomized Controlled Trial of Two Treatment for a Mallet Finger of Tendinous Origin

Second Affiliated Hospital of Wenzhou Medical University0 sites48 target enrollmentMarch 25, 2019
ConditionsMallet Finger

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mallet Finger
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Enrollment
48
Primary Endpoint
Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2019
End Date
June 30, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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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