Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children

Overview

The standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient.

Full Title of Study: “Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 29, 2019

Detailed Description

Children with distal radial or forearm fractures needing closed reduction are eligible for this study. By drawing lots either an immobilization with an upper arm or forearm combicast will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be performed to check the rate of displacement, consolidation time, wearing comfort and movement of the elbow joint after taking off the cast.

Interventions

  • Device: combi cast
    • upper arm or forearm combi cast

Arms, Groups and Cohorts

  • Active Comparator: upper arm combi cast
    • standardized treatment
  • Experimental: forearm combi cast
    • Treatment with a forearm combi cast should be a sufficient immobilization

Clinical Trial Outcome Measures

Primary Measures

  • secondary displacement of the fracture
    • Time Frame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
    • radiological evaluation

Secondary Measures

  • Wearing comfort of the two different casts
    • Time Frame: 5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
    • help in daily life in hours
  • Mobilisation of elbow joint after cast removal
    • Time Frame: 4 weeks and 7 weeks after closed reduction of fracture
    • Mobility of the elbow joint in degrees (flection and extension measurement)

Participating in This Clinical Trial

Inclusion Criteria

  • open growth Zone – displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction – written informed consent Exclusion Criteria:

  • intraarticular fractures – open fractures – unstable fractures

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Children’s Hospital, Zurich
  • Provider of Information About this Clinical Study
    • Principal Investigator: Georg Staubli, Dr. med. – University Children’s Hospital, Zurich
  • Overall Official(s)
    • Georg Staubli, Dr. med, Principal Investigator, Emergency department, University Children’s Hospital Zurich

References

Paneru SR, Rijal R, Shrestha BP, Nepal P, Khanal GP, Karn NK, Singh MP, Rai P. Randomized controlled trial comparing above- and below-elbow plaster casts for distal forearm fractures in children. J Child Orthop. 2010 Jun;4(3):233-7. doi: 10.1007/s11832-010-0250-1. Epub 2010 Mar 17.

Webb GR, Galpin RD, Armstrong DG. Comparison of short and long arm plaster casts for displaced fractures in the distal third of the forearm in children. J Bone Joint Surg Am. 2006 Jan;88(1):9-17. doi: 10.2106/JBJS.E.00131.

Boyer BA, Overton B, Schrader W, Riley P, Fleissner P. Position of immobilization for pediatric forearm fractures. J Pediatr Orthop. 2002 Mar-Apr;22(2):185-7.

Bhatia M, Housden PH. Re-displacement of paediatric forearm fractures: role of plaster moulding and padding. Injury. 2006 Mar;37(3):259-68. doi: 10.1016/j.injury.2005.10.002. Epub 2006 Jan 18. Erratum In: Injury. 2006 Aug;37(8):801.

Katz K, Weigl D, Becker T, Attias J, Bar-On E. Short-term after-effect of forearm cast removal in children. J Orthop Sci. 2011 May;16(3):283-5. doi: 10.1007/s00776-011-0054-2. Epub 2011 Mar 29.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.