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

NCT01759758 | Completed

• 1 other identifier: IWK-1012457
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

boxer's fracture; metacarpal neck fracture; metacarpal fracture

Outcome Measures

Primary Outcomes (2)

• Range of Motion

  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

  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 Outcomes (5)

• Pain

  1, 3, 6, and 12 weeks post fracture

• Complications

  3, 6, and 12 weeks

• Validated Outcome Questionnaire

  3, 6, and 12 weeks

• Grip Strength

  6 and 12 weeks

• Radiographic assessment of fracture

  12 weeks post fracture

Study Arms (2)

Plaster Ulnar Gutter Splint

ACTIVE COMPARATOR

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

Thermoplastic Splint

EXPERIMENTAL

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

Interventions

Plaster Ulnar Gutter Splint OTHER

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

Also known as: Conventional Plaster splint, Plaster of Paris

Plaster Ulnar Gutter Splint

Thermoplastic Splint OTHER

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.

Also known as: Functional brace, Moulded brace, Moulded Metacarpal brace

Thermoplastic Splint

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K6R8, Canada

Location

Related Publications (13)

• 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. No abstract available.

  PMID: 4247878 BACKGROUND

• 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;2005(3):CD003210. doi: 10.1002/14651858.CD003210.pub3.

  PMID: 16034891 BACKGROUND

• 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. doi: 10.1016/s0020-1383(97)00106-x.

  PMID: 9659472 BACKGROUND

• 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. doi: 10.1054/jhsb.2000.0509.

  PMID: 11386781 BACKGROUND

• Kuokkanen HO, Mulari-Keranen 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. doi: 10.1080/02844319950159299.

  PMID: 10505445 BACKGROUND

• 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. doi: 10.1007/s00402-003-0580-2. Epub 2003 Aug 28.

  PMID: 14639483 BACKGROUND

• 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. doi: 10.1016/s0266-7681(98)80186-1.

  PMID: 9607671 BACKGROUND

• 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. doi: 10.3109/17453679008993576.

  PMID: 2281761 BACKGROUND

• 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.

  PMID: 20357591 BACKGROUND

• 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.

  PMID: 20659966 BACKGROUND

• 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.

  PMID: 18929202 BACKGROUND

• 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. doi: 10.1097/01.bpo.0000149866.80894.70.

  PMID: 15832164 BACKGROUND

• Davison PG, Boudreau N, Burrows R, Wilson KL, Bezuhly M. Forearm-Based Ulnar Gutter versus Hand-Based Thermoplastic Splint for Pediatric Metacarpal Neck Fractures: A Blinded, Randomized Trial. Plast Reconstr Surg. 2016 Mar;137(3):908-916. doi: 10.1097/01.prs.0000479974.45051.78.

  PMID: 26910672 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Calcium Sulfate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Michael Bezuhly, MD, MSc, SM

  Assistant Professor, Clinician-Investigator at IWK Health Centre and Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Clinical Investigator

Study Record Dates

• First Submitted: December 30, 2012
• First Posted: January 3, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

CA (1)