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A Randomized Trial Comparing Conventional Plaster and Thermoplastic Splints to Treat Pediatric Boxer's Fractures

NCT01759758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-01-13

No results posted yet for this study

Summary

The investigators are conducting a randomized clinical trial comparing two types of splints for treatment of Boxer's fractures in children up to age 17 inclusive. Patients who meet inclusion criteria will be randomized to either Group A or B. Group A will be treated with the conventional plaster ulnar gutter splint. Group B will be treated with a custom molded thermoplastic hand-based splint. The thermoplastic splint will provide support of the metacarpal but does not immobilize the patient's wrist or interphalangeal joints.

Hypothesis: Is plaster splint immobilization an equivalent treatment method to a custom made thermoplastic splint for a fifth metacarpal neck fracture? Will one splint be tolerated better than the other and will the compliance be different between the two groups?

Conditions

  • Bone Fractures
  • Splints
  • Metacarpal Fracture
  • Boxer's Fracture

Interventions

OTHER

Plaster Ulnar Gutter Splint

Patients are placed in a plaster ulnar gutter splint, molded in the safe position.

OTHER

Thermoplastic Splint

Thermoplastic Splint is heat moulded to the patient's hand, stabilizing the metacarpal heads, but not immobilizing any joints. This is done by our occupational therapist.

Sponsors & Collaborators

  • IWK Health Centre

    lead OTHER

Principal Investigators

  • Michael Bezuhly, MD, MSc, SM · Assistant Professor, Clinician-Investigator at IWK Health Centre and Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Canada

Study Locations

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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 NCT01759758 on ClinicalTrials.gov