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Mallet FingerPhase 3NCT00868686

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

A Phase 3 study testing Volar aluminum splint, Dorsal aluminum splint and Custom thermoplastic in people with Mallet Finger, run by St. Paul's Hospital, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mallet Finger
What is being tested?
Volar aluminum splint, Dorsal aluminum splint and Custom thermoplastic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteCanada
Study dates
Oct 2005to Jul 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: Blinded, Prospective, Randomized Clinical Trial Comparing Volar, Dorsal, and Custom Thermoplastic Splinting in the Treatment of Acute Mallet Finger

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.

Read the 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.

Conditions
Mallet Finger
Being tested
Volar aluminum splint, Dorsal aluminum splint, Custom thermoplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volar aluminum splintDevice

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

  • Dorsal aluminum splintDevice

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

  • Custom thermoplasticDevice

    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.

Study groups in NCT00868686
Study groupRoleWhat they receive
Volar aluminum splintActive comparatorNot described
Receives: Device: Volar aluminum splint
Dorsal aluminum splintActive comparatorNot described
Receives: Device: Dorsal aluminum splint
Custom thermoplasticActive comparatorNot described
Receives: Device: Custom thermoplastic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic lag difference

    Measured: Week-12 timepoint

Secondary outcomes (1)
  1. 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.

    Measured: Week-12 and Week-24 Timepoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2009 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00868686
Sponsor's protocol ID
H05-50193
Status last verified
Mar 2009
First submitted
24 Mar 2009
Last updated
25 Mar 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Volar aluminum splint, Dorsal aluminum splint and Custom thermoplastic in people with Mallet Finger, run by St. Paul's Hospital, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic lag difference (time frame: Week-12 timepoint). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2009.

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