Two Treatment for a Mallet Finger of Tendinous Origin

Not Applicable

• Conditions: Mallet Finger
• Interventions: Procedure: custom thermoplastic orthosis

• Registration Number: NCT03899363
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-19
• Study Start: 2019-03-25
• Study First Submitted QC: 2019-03-31
• Last Update Submitted: 2019-03-31
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
custom thermoplastic orthosis	custom thermoplastic orthosis	-
surgery	custom thermoplastic orthosis	-

Primary Outcome Measures

Name	Time	Method
Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed	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.