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

January 12, 2016 updated by: Michael Bezuhly, IWK Health Centre

Conventional Plaster Versus Thermoplastic Splint for the Treatment of a Pediatric Metacarpal Neck Fracture: a Randomized Trial

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?

Study Overview

Detailed Description

Nearly all Boxer's fractures are treated without surgery using a splint to keep part or all of the hand from moving (immobilization). There are several acceptable methods of immobilization used by hand surgeons, using splints of different sizes and materials for variable periods of time(1-6).

A recent systematic review from The Cochrane Collaboration found the current data to be inconclusive with regards to the optimal immobilization technique and highlighted the need for further studies(2). Specifically, it was recommended that future studies include functional outcome measures, timing of return to work, complications, pain scores, and an economic analysis.

The current practice at the investigators' institution is for patients to be splinted in a plaster ulnar gutter splint, in the Emergency Department and referred to the next available plastic surgery clinic. If needed, a closed reduction would be performed in clinic, if there was a significant angulation (greater than 45 degrees) or any clinical rotation deformity. The most common method of immobilization involves placing the wrist, ring finger and little finger all the way from the fingertips to the mid-forearm in molded plaster called an ulnar gutter splint. The splint is left on 24 hours a day for 3 to 4 weeks and then removed in the clinic.

Many patients find it difficult to keep the splint on for the full 3 to 4 weeks for a number of reasons. The plaster needs to stay dry, making it awkward to bathe. The splint can also get loose and rub as the swelling around the fracture gets better. The splint can also start to smell because sweat builds up under it. Some patients find the plaster material heavy, making it difficult to wear. Finally, many patients are self-conscious about the appearance of the splint and remove it for this reason alone. In the investigators' experience, up to 1 out of 5 patients will remove the splint on their own against doctor's orders for one reason or another. When patients do follow instructions and keep the splint on 24 hours a day for 3 to 4 weeks, this can lead to joint stiffness when the splint is removed. Some patients may even require physiotherapy to regain their normal finger movement and grip strength.

It is unknown if the ulnar gutter splint is really the best way to immobilize the hand after a Boxer's fracture. It is unknown what material is best for making the splint, whether it is truly necessary to keep the entirety of the wrist and ring and little fingers still, and for how long the hand and fingers should be kept still. Most surgeons recommend patients wear a splint for 3 to 4 weeks.

The investigators would like to determine if a smaller splint made of more durable, lighter moldable plastic that allows earlier movement of the hand and fingers while still keeping the fracture from moving gives the same result as the commonly used ulnar gutter splint.

Functional Hand Based Splint (Thermoplastic Splint) The functional hand-based splint is made of custom molded hard plastic and is fitted over the hand only. A thermoplastic splint is made from plastic that is heated and custom-fitted to the subject's hand, which hardens when it cools. This thermoplastic splint is custom fitted by an occupational therapist such that all joints are free to move. The splint does not limit the patient from moving their wrist or fingers while wearing it. It is custom molded such that it fits snuggly over the patient's hand and holds the fracture in a stable position.

Several adult studies have found this type of custom molded splint superior to either surgical treatment and/or plaster splint immobilization because it resulted in less stiffness, better movement after splint removal, and no increased pain (4-7). The investigators are not aware of any comparative studies done in pediatric patients.

Compliance Patient compliance for wearing their splint for the prescribed during can be a problem. At the investigators' institution, there is a non-compliance rate of approximately 15 to 20 % for Boxer's fracture patients. The investigators hypothesize that the hand-based splint will be better tolerated by patients and therefore result in a higher rate of compliance for the prescribed duration that the plaster splint. Also, the thermoplastic splint will not be damaged if it gets wet, which may translate into fewer additional visits to the clinic or emergency department to have the splint replaced.

This study will be a randomized, single-blinded controlled trial. The randomization of the two splint types will be determined by a computer-based number generator. The patients will know what type of splint they have, but the plastic surgeons and physiotherapist who examine and test the subjects ROM and grip strength will not know the type of splint for each subject.

Patients will be randomized to one of the two groups at their first clinic visit, within 7 days of their injury. They will have their splint placed at this visit and are to wear the splint at all times for 3 weeks. Subjects will return to clinic at 1, 3, 6, and 12 weeks to be reassessed. Specified outcome measures (primary and secondary) will be tested at each visit.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: up to 12 weeks
The active and passive Range of Motion (ROM) will be tested at 3 time points, for all fingers and the wrist
up to 12 weeks
Compliance
Time Frame: 3 weeks post fracture
The compliance rate of subjects in each group wearing the splint at all times for the prescribed duration (3 weeks) will be assessed.
3 weeks post fracture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 1, 3, 6, and 12 weeks post fracture
Pain, reported on a Visual Analog Scale, will be assessed at specified time points
1, 3, 6, and 12 weeks post fracture
Complications
Time Frame: 3, 6, and 12 weeks
Loss of fracture reduction, malunion or non-union will be monitored throughout the study
3, 6, and 12 weeks
Validated Outcome Questionnaire
Time Frame: 3, 6, and 12 weeks
Patients will complete the Pediatric Outcomes Data Collection Instrument (PODCI) at several time points
3, 6, and 12 weeks
Grip Strength
Time Frame: 6 and 12 weeks
Patients will have their grip strength measured for the injured and non-injured hand at 6 and 12 weeks post fracture
6 and 12 weeks
Radiographic assessment of fracture
Time Frame: 12 weeks post fracture
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
12 weeks post fracture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 30, 2012

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IWK-1012457

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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