CompletedPhase 3

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

Canada77 participantsStarted 2005-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographic lag difference

Timeframe: Week-12 timepoint

Trial details

NCT IDNCT00868686

SponsorSt. Paul's Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-07

View on ClinicalTrials.gov More Mallet Finger trials