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

Radius Fractures Clinical Trial

Official title:

Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297047
• Other study ID #: Forearm combi cast 2016
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: August 29, 2019

Study information

• Verified date: September 2019
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone
• Radius Fractures
• Salter-Harris Type 2
• Salter-Harris Type I

Intervention

Device:
• combi cast
upper arm or forearm combi cast

Locations

Country	Name	City	State
Switzerland	Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	secondary displacement of the fracture	radiological evaluation	Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
Secondary	Wearing comfort of the two different casts	help in daily life in hours	5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
Secondary	Mobilisation of elbow joint after cast removal	Mobility of the elbow joint in degrees (flection and extension measurement)	4 weeks and 7 weeks after closed reduction of fracture