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

Primary Purpose

Salter-Harris Type I, Salter-Harris Type 2, Radius Fractures

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
combi cast
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Salter-Harris Type I focused on measuring cast, fracture, immobilization, displacement, child

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

upper arm combi cast

forearm combi cast

Arm Description

standardized treatment

Treatment with a forearm combi cast should be a sufficient immobilization

Outcomes

Primary Outcome Measures

secondary displacement of the fracture
radiological evaluation

Secondary Outcome Measures

Wearing comfort of the two different casts
help in daily life in hours
Mobilisation of elbow joint after cast removal
Mobility of the elbow joint in degrees (flection and extension measurement)

Full Information

First Posted
July 27, 2017
Last Updated
September 16, 2019
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03297047
Brief Title
Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children
Official Title
Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
August 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salter-Harris Type I, Salter-Harris Type 2, Radius Fractures, Forearm Fracture
Keywords
cast, fracture, immobilization, displacement, child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one Group with upper arm cast one Group with forearm cast
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
upper arm combi cast
Arm Type
Active Comparator
Arm Description
standardized treatment
Arm Title
forearm combi cast
Arm Type
Experimental
Arm Description
Treatment with a forearm combi cast should be a sufficient immobilization
Intervention Type
Device
Intervention Name(s)
combi cast
Intervention Description
upper arm or forearm combi cast
Primary Outcome Measure Information:
Title
secondary displacement of the fracture
Description
radiological evaluation
Time Frame
Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
Secondary Outcome Measure Information:
Title
Wearing comfort of the two different casts
Description
help in daily life in hours
Time Frame
5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
Title
Mobilisation of elbow joint after cast removal
Description
Mobility of the elbow joint in degrees (flection and extension measurement)
Time Frame
4 weeks and 7 weeks after closed reduction of fracture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Staubli, Dr. med
Organizational Affiliation
Emergency department, University Children's Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21629372
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.
Results Reference
background
PubMed Identifier
16391244
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. doi: 10.2106/JBJS.E.00131.
Results Reference
background
PubMed Identifier
11856927
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.
Results Reference
background
PubMed Identifier
16414049
Citation
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.
Results Reference
background
PubMed Identifier
21590522
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.
Results Reference
background
PubMed Identifier
32940750
Citation
Seiler M, Heinz P, Callegari A, Dreher T, Staubli G, Aufdenblatten C. Short and long-arm fiberglass cast immobilization for displaced distal forearm fractures in children: a randomized controlled trial. Int Orthop. 2021 Mar;45(3):759-768. doi: 10.1007/s00264-020-04800-w. Epub 2020 Sep 17.
Results Reference
derived

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

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