MedTrace Logo

Clinical Trial Comparing Volar, Dorsal, and Custom Thermoplastic Splinting in the Treatment of Acute Mallet Finger

NCT00868686 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2009-03-25

No results posted yet for this study

Summary

In most cases of acute mallet finger, or avulsion of the extensor digitorum communis terminal tendon from the distal phalanx, splinting is the treatment strategy employed. The type of splint used to treat these injuries continues to be controversial. Custom splints have recently been advocated though no strong comparative evidence is available.

The primary objective of this investigation was to show superiority of the custom thermoplastic splint over both the dorsal and volar non-custom splints. The null hypothesis was that a radiographic lag difference greater than 5 degrees would not be observed between groups. The primary outcome measure is the residual extensor lag difference (compared to the contralateral equivalent digit) at 12 weeks post-splinting.

Conditions

  • Mallet Finger

Interventions

DEVICE

Volar aluminum splint

Alumafoam strip with padding removed, placed on the VOLAR aspect of the digit spanning the middle and distal phalanges only.

DEVICE

Dorsal aluminum splint

Alumafoam strip with padding removed, placed on the DORSAL aspect of the digit spanning the middle and distal phalanges only.

DEVICE

Custom thermoplastic

Customized thermoplastic splint with circumferential contact proximal to the joint and volar contact distal to the joint. This is a similar design to the original Stack splint, except that it is custom molded.

Sponsors & Collaborators

  • Canadian Orthopaedic Foundation

    collaborator OTHER

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Jeffrey M Pike, MD · St. Paul's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868686 on ClinicalTrials.gov