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

• Sponsor: University Children's Hospital, Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT03297047
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.9
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Salter-Harris Type I; Salter-Harris Type 2; Radius Fractures; Forearm Fracture	Device: combi cast	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: one Group with upper arm cast one Group with forearm castone Group with upper arm cast one Group with forearm cast
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children
• Actual Study Start Date: Oct 2, 2017
• Actual Primary Completion Date: Aug 29, 2019
• Actual Study Completion Date: Aug 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: upper arm combi cast standardized treatment	Device: combi cast; upper arm or forearm combi cast
Experimental: forearm combi cast Treatment with a forearm combi cast should be a sufficient immobilization	Device: combi cast; upper arm or forearm combi cast

Outcome Measures

Primary Outcome Measures

1. secondary displacement of the fracture [Significant difference of secondary displaced fractures 28 days after closed reduction of fracture]

   radiological evaluation

Secondary Outcome Measures

1. Wearing comfort of the two different casts [5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture]

   help in daily life in hours

2. Mobilisation of elbow joint after cast removal [4 weeks and 7 weeks after closed reduction of fracture]

   Mobility of the elbow joint in degrees (flection and extension measurement)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital	Zurich		Switzerland	8032

Sponsors and Collaborators

• University Children's Hospital, Zurich

Investigators

• Principal Investigator: Georg Staubli, Dr. med, Emergency department, University Children's Hospital Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Georg Staubli, Dr. med., University Children's Hospital, Zurich
• ClinicalTrials.gov Identifier: NCT03297047
• Other Study ID Numbers: Forearm combi cast 2016
• First Posted: Sep 29, 2017
• Last Update Posted: Sep 17, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Georg Staubli, Dr. med., University Children's Hospital, Zurich: cast, fracture, immobilization, displacement, child
• Additional relevant MeSH terms: Fractures, Bone; Radius Fractures

Study Results

No Results Posted as of Sep 17, 2019