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

NCT00868686 | Completed Phase 3

• 1 other identifier: H05-50193
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Radiographic lag difference

  Week-12 timepoint

Secondary Outcomes (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.

  Week-12 and Week-24 Timepoint

Study Arms (3)

Volar aluminum splint

ACTIVE COMPARATOR

Device: Volar aluminum splint

Dorsal aluminum splint

ACTIVE COMPARATOR

Device: Dorsal aluminum splint

Custom thermoplastic

ACTIVE COMPARATOR

Device: Custom thermoplastic

Interventions

Volar aluminum splint DEVICE

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

Volar aluminum splint

Dorsal aluminum splint DEVICE

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

Dorsal aluminum splint

Custom thermoplastic DEVICE

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.

Custom thermoplastic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead
• Canadian Orthopaedic Foundation: collaborator

Study Sites (1)

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Study Officials

• Jeffrey M Pike, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: October 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 25, 2009

Record last verified: 2009-03

Locations

CA (1)