Two Treatment for a Mallet Finger of Tendinous Origin
A Prospective, Randomized Controlled Trial of Two Treatment for a Mallet Finger of Tendinous Origin
1 other identifier
interventional
48
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedApril 2, 2019
March 1, 2019
2 years
March 19, 2019
March 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
surgery
EXPERIMENTALcustom thermoplastic orthosis
ACTIVE COMPARATORInterventions
extended the DIP by a custom thermoplastic orthosis or the Kirschner wire through the joint
Eligibility Criteria
You may qualify if:
- Diagnosis of a mallet finger, with or without fracture;
- Age≥18 years
You may not qualify if:
- Open lesions
- Mallet fractures with subluxation of the DIP
- Delays in treatment \>2 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2019
First Posted
April 2, 2019
Study Start
March 25, 2019
Primary Completion
March 30, 2021
Study Completion
June 30, 2021
Last Updated
April 2, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share