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

This study has been completed.
Sponsor:
Collaborator:
Canadian Orthopaedic Foundation
Information provided by:
St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00868686
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Mallet Finger
Device: Volar aluminum splint
Device: Dorsal aluminum splint
Device: Custom thermoplastic
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blinded, Prospective, Randomized Clinical Trial Comparing Volar, Dorsal, and Custom Thermoplastic Splinting in the Treatment of Acute Mallet Finger

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • Radiographic lag difference [ Time Frame: Week-12 timepoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlations between residual lag and patient age, MHQ scores, and complications; incidence of complications; comparing radiographic to clinical extensor lag differences; and evaluating the course of residual lag post splinting. [ Time Frame: Week-12 and Week-24 Timepoint ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: October 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Volar aluminum splint Device: Volar aluminum splint
Alumafoam strip with padding removed, placed on the VOLAR aspect of the digit spanning the middle and distal phalanges only.
Active Comparator: Dorsal aluminum splint Device: Dorsal aluminum splint
Alumafoam strip with padding removed, placed on the DORSAL aspect of the digit spanning the middle and distal phalanges only.
Active Comparator: Custom thermoplastic 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.

Detailed Description:

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. These are considered Doyle I injuries- closed injuries with or without a small (<20%) avulsion fragment. Absolute and relative indications for surgical intervention include an open injury, or a bony mallet involving greater than 20% of the articular surface of the distal phalanx with volar subluxation of the distal phalanx relative to the proximal phalanx. The type of splint used to treat Doyle I mallet injuries continues to be controversial. Custom splints have recently been advocated though no strong comparative evidence is available.

Objectives. 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. Week-12 was chosen as a compromise between minimizing drop-out and the most distant timepoint reasonably obtainable.

A novel outcome lag measurement was developed for this study, using the contralateral normal digit as an internal control for establishing residual extensor lag. The residual extensor lag difference was calculated with a single radiograph obtained with the beam directed laterally at the affected digit and the contralateral equivalent digit (Figure 2). For example, if the injured mallet finger was the right index finger, a single lateral radiograph of the right and left index fingers on the same film was obtained. The patient was instructed to maximally extend the both digits. This allowed for accurate determination of extensor lag and comparison with the unaffected side . Adequacy of the lateral view was assessed by considering the superimposition of the phalangeal condyles of the affected digit. If they were not not superimposed, the radiograph was repeated.

A pilot study was performed to establish the most reliable technique for measuring residual lag radiographically. Three measurement techniques were trialled by individuals with three levels of training: resident, fellow, and consultant staff. A clearly defined technique was employed using digital images only (Inteleviewer, Intelerad, Montreal, Canada). The radiograph was enlarged on the viewing monitor so that the middle and distal phalanges maximally filled the screen. The techniques used bisecting lines for the middle and distal phalanges referencing either the volar cortex, dorsal cortex, or longitudinal axis of the phalanges (Figure 3). Twenty-six lateral finger radiographs were blinded and assessed, and then repeat measurements were obtained three weeks later. Inter-item correlation matrices and intraobserver Pearson's correlations showed extremely high correlation values ranging from 0.993 to 0.999 for the longitudinal axis technique. This pilot study established the longitudinal axis technique as the most reliable in measuring residual radiographic lag.

Several secondary objectives were investigated. These included correlations between residual lag and other factors, including patient age, Michigan Hand Outcome Questionnaire scores (MHQ) and the development of complications; incidence of complications in each splinting group; comparing radiographic to clinical extensor lag differences; and evaluating the course of residual lag after splinting has been discontinued. Exploratory analyses were performed as hypothesis generators only, including sub-group analysis.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients identified as having an acute mallet finger (defined as mallet injuries all digits excluding the thumb presenting less than 28 days since injury)

Exclusion Criteria:

  • open injury
  • an intra-articular fragment of the distal phalanx involved greater than one third of articular surface
  • DIP joint subluxation
  • pre-existing arthritis of the DIP joint was present
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868686

Locations
Canada, British Columbia
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Canadian Orthopaedic Foundation
Investigators
Principal Investigator: Jeffrey M Pike, MD St Paul's Hospital
  More Information

No publications provided

Responsible Party: Jeffrey Pike, St Paul's Hospital
ClinicalTrials.gov Identifier: NCT00868686     History of Changes
Other Study ID Numbers: H05-50193
Study First Received: March 24, 2009
Last Updated: March 24, 2009
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 18, 2014