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

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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

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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

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:

Hunter JM, Cowen NJ. Fifth metacarpal fractures in a compensation clinic population. A report on one hundred and thirty-three cases. J Bone Joint Surg Am. 1970 Sep;52(6):1159-65.

Poolman RW, Goslings JC, Lee JB, Statius Muller M, Steller EP, Struijs PA. Conservative treatment for closed fifth (small finger) metacarpal neck fractures. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003210. Review.

Braakman M, Oderwald EE, Haentjens MH. Functional taping of fractures of the 5th metacarpal results in a quicker recovery. Injury. 1998 Jan;29(1):5-9. PubMed PMID: 9659472.

Harding IJ, Parry D, Barrington RL. The use of a moulded metacarpal brace versus neighbour strapping for fractures of the little finger metacarpal neck. J Hand Surg Br. 2001 Jun;26(3):261-3.

Kuokkanen HO, Mulari-Keränen SK, Niskanen RO, Haapala JK, Korkala OL. Treatment of subcapital fractures of the fifth metacarpal bone: a prospective randomised comparison between functional treatment and reposition and splinting. Scand J Plast Reconstr Surg Hand Surg. 1999 Sep;33(3):315-7.

Statius Muller MG, Poolman RW, van Hoogstraten MJ, Steller EP. Immediate mobilization gives good results in boxer's fractures with volar angulation up to 70 degrees: a prospective randomized trial comparing immediate mobilization with cast immobilization. Arch Orthop Trauma Surg. 2003 Dec;123(10):534-7. Epub 2003 Aug 28.

Hansen PB, Hansen TB. The treatment of fractures of the ring and little metacarpal necks. A prospective randomized study of three different types of treatment. J Hand Surg Br. 1998 Apr;23(2):245-7.

Konradsen L, Nielsen PT, Albrecht-Beste E. Functional treatment of metacarpal fractures 100 randomized cases with or without fixation. Acta Orthop Scand. 1990 Dec;61(6):531-4.

Sawyer JR, Ivie CB, Huff AL, Wheeler C, Kelly DM, Beaty JH, Canale ST. Emergency room visits by pediatric fracture patients treated with cast immobilization. J Pediatr Orthop. 2010 Apr-May;30(3):248-52. doi: 10.1097/BPO.0b013e3181d213bc.

Strub B, Schindele S, Sonderegger J, Sproedt J, von Campe A, Gruenert JG. Intramedullary splinting or conservative treatment for displaced fractures of the little finger metacarpal neck? A prospective study. J Hand Surg Eur Vol. 2010 Nov;35(9):725-9. doi: 10.1177/1753193410377845. Epub 2010 Jul 21.

Hofmeister EP, Kim J, Shin AY. Comparison of 2 methods of immobilization of fifth metacarpal neck fractures: a prospective randomized study. J Hand Surg Am. 2008 Oct;33(8):1362-8. doi: 10.1016/j.jhsa.2008.04.010.

Lerman JA, Sullivan E, Barnes DA, Haynes RJ. The Pediatric Outcomes Data Collection Instrument (PODCI) and functional assessment of patients with unilateral upper extremity deficiencies. J Pediatr Orthop. 2005 May-Jun;25(3):405-7.

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:	January 2, 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 May 16, 2013