Two Treatment for a Mallet Finger of Tendinous Origin

Mallet Finger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03899363
• Other study ID #: SAHoWMU-CR2018-08-417
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: June 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mallet Finger

Intervention

Procedure:
• custom thermoplastic orthosis
extended the DIP by a custom thermoplastic orthosis or the Kirschner wire through the joint

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)