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Two Treatment for a Mallet Finger of Tendinous Origin

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03899363
Enrollment
48
Registered
2019-04-02
Start date
2019-03-25
Completion date
2021-06-30
Last updated
2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mallet Finger

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.

Interventions

PROCEDUREcustom thermoplastic orthosis

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

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completedThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026