Two Treatment for a Mallet Finger of Tendinous Origin

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

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.

Study Overview

• Status: Unknown
• Conditions: Mallet Finger
• Intervention / Treatment: Procedure: custom thermoplastic orthosis

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Kirschner wire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed	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.	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)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 25, 2019
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 31, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 31, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SAHoWMU-CR2018-08-417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No