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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by IWK Health Centre
Sponsor:
Information provided by (Responsible Party):
Michael Bezuhly, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01759758
First received: December 30, 2012
Last updated: October 26, 2013
Last verified: October 2013
  Purpose

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?


Condition Intervention
Bone Fractures
Splints
Metacarpal Fracture
Boxer's Fracture
Other: Plaster Ulnar Gutter Splint
Other: Thermoplastic Splint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conventional Plaster Versus Thermoplastic Splint for the Treatment of a Pediatric Metacarpal Neck Fracture: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Range of Motion [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    The active and passive Range of Motion (ROM) will be tested at 3 time points, for all fingers and the wrist

  • Compliance [ Time Frame: 3 weeks post fracture ] [ Designated as safety issue: No ]
    The compliance rate of subjects in each group wearing the splint at all times for the prescribed duration (3 weeks) will be assessed.


Secondary Outcome Measures:
  • Pain [ Time Frame: 1, 3, 6, and 12 weeks post fracture ] [ Designated as safety issue: No ]
    Pain, reported on a Visual Analog Scale, will be assessed at specified time points

  • Complications [ Time Frame: 3, 6, and 12 weeks ] [ Designated as safety issue: No ]
    Loss of fracture reduction, malunion or non-union will be monitored throughout the study

  • Validated Outcome Questionnaire [ Time Frame: 3, 6, and 12 weeks ] [ Designated as safety issue: No ]
    Patients will complete the Pediatric Outcomes Data Collection Instrument (PODCI) at several time points

  • Grip Strength [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
    Patients will have their grip strength measured for the injured and non-injured hand at 6 and 12 weeks post fracture

  • Radiographic assessment of fracture [ Time Frame: 12 weeks post fracture ] [ Designated as safety issue: No ]
    An X-ray of the injured had will be done in 3 views. This will be assessed by one of the investigators, in a blinded fashion. They will determine the angulation and assess for evidence of bony healing


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plaster Ulnar Gutter Splint
Patients will have their hand placed in a conventional Plaster ulnar gutter splint. This immobilizes all joints of the ring and small fingers and the wrist
Other: Plaster Ulnar Gutter Splint
Patients are placed in a plaster ulnar gutter splint, molded in the safe position.
Other Names:
  • Conventional Plaster splint
  • Plaster of Paris
Experimental: Thermoplastic Splint
Patients will be fitted with a custom molded thermoplastic splint that stabilizes the metacarpals of the injured hand but does not immobilize any joints
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.
Other Names:
  • Functional brace
  • Moulded brace
  • Moulded Metacarpal brace

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Isolated 5th metacarpal neck fracture
  • Less than 10 days from injury

Exclusion Criteria:

  • Multiple Metacarpal fractures
  • Significant injuries to other hand structures (tendons, nerves, major arteries)
  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: NCT01759758

Contacts
Contact: Michael Bezuhly, MD, MSc, SM 902-470-8168 Michael.Bezuhly@iwk.nshealth.ca

Locations
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K6R8
Contact: Michael Bezuhly, MD, MSc, SM    902-470-8168    Michael.Bezuhly@iwk.nshealth.ca   
Principal Investigator: Michael Bezuhly, MD, MSc, SM         
Sub-Investigator: Ken Wilson, MD         
Sub-Investigator: Peter Davison, MD         
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Michael Bezuhly, MD, MSc, SM Assistant Professor, Clinician-Investigator at IWK Health Centre and Dalhousie University
  More Information

Publications:

Responsible Party: Michael Bezuhly, Assistant Professor, Clinical Investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01759758     History of Changes
Other Study ID Numbers: IWK-1012457
Study First Received: December 30, 2012
Last Updated: October 26, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by IWK Health Centre:
boxer's fracture
metacarpal neck fracture
metacarpal fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014