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Trial registered on ANZCTR


Registration number
ACTRN12611000101987
Ethics application status
Not yet submitted
Date submitted
26/01/2011
Date registered
31/01/2011
Date last updated
31/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Long Arm Casting Versus Splinting After Manipulation of Distal Third Radius Fractures in Children
Scientific title
Pediatric Distal Third Radius Fractures Treated with Long Arm Casting Versus Sugar Tong Splinting : A Comparison of Re-reduction Rates
Secondary ID [1] 253484 0
Auckland District Health Board - ADHB5006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal Radius Fractures 261036 0
Condition category
Condition code
Musculoskeletal 259174 259174 0 0
Other muscular and skeletal disorders
Injuries and Accidents 259184 259184 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sugar Tong Splint. A sugar tong splint is made of paris of plaster and goes along the posterior aspect of the elbow and extends along the front and back of the forearm and wrist. The sides of the forearm and wrist are left free to allow for swelling. The splint is wrapped with an elastic bandage and immobilizes the elbow, forearm, and wrist. This will be administered by the on call registrar in the emergency department at the time of the initial consultation.

The elastic bandage about the sugar tong splint will be tightened at week 1 if the splint has loosened. The splint will then be changed to an above elbow cast at the 2 week visit assuming no loss of reduction. This cast will be placed by the clinic nurses in fracture clinic. The cast will be maintained for 3-4 weeks.
Intervention code [1] 257918 0
Treatment: Devices
Comparator / control treatment
Above Elbow Casting. An above elbow plaster of paris cast will be placed by the on call orthopaedic registrar in the emergency department at the time of the initial consultation. This plaster goes around the entire arm from the upper arm through the hand to provide rigid, circumferential immobilization of the affected arm. The cast will be left on for a total of 5-6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 262025 0
Remanipulation rates. X-rays of the fractured wrist will be taken at 1,2, and 6 weeks after initial manipulation and immobilization. These x-rays will be evaluated by the primary investigator. If there is angulation of >20 degrees on either the AP or lateral x-ray of the wrist, the patient will need to undergo remanipulation of the wrist under general anesthesia.
Timepoint [1] 262025 0
1, 2, and 6 weeks after initial manipulation and immobilization
Secondary outcome [1] 268973 0
Cast Complications. Patients and parents will be given a questionnaire form at the 6 week visit asking if they 1) ever had their cast split during the treatment period due to the cast being too tight and 2) needed the cast to be replaced or overwrapped due to the cast loosening or breaking. In addition, patients and parents will be asked the same questions during their 1, 2, and 6 week visits by the orthopaedic registrar/fellow that evaluates them in clinic.
Timepoint [1] 268973 0
1,2, and 6 weeks after initial manipulation and immobilization

Eligibility
Key inclusion criteria
Pediatric patients age 3-14 years old that 1) are diagnosed with distal third radius fractures with or without associated ulna frctures, 2) require closed reduction of the fracture, 3) are treated with closed reduction at Starship Childrens Hospital, and 4) informed consent is obtained.
Minimum age
3 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Open fractures, 2) fractures manipulated outside of Starship Childrens Hospital, 3) nondisplaced fractures or those fractures not requiring reduction, and 4) any irreducible fracture requiring open reduction and/or internal fixation or percutaneous wiring.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants in the study will be identified in the emergency department by the orthopaedic registrar on call. Patients qualifying for the study will be given information sheets regarding the study by the emergency department nurses and the orthopaedic on call registrar will discuss the study with the patients and parents. If a patient decides to participate in the study, they will be treated with manipulation and either casting or splinting.

Prior to starting the study, a computer generated randomized sequence of interventions (cast or splint) will be performed. Based on this randomized sequence, patients will then be treated with either a splint or a cast as they are enrolled into the study. 100 sealed opaque envelopes will be marked 1-100 and a piece of paper stating either “cast” or “splint” will be placed inside each envelope as determined by the randomized sequence. These envelopes will be made by an independent person not involved in the study so that the order is not known to any of the treating physicians. The on call registrars enrolling patients will not know the method of treatment until patients have agreed to participate in the study and the envelope has been opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to starting the study, a computer generated randomized sequence of interventions (cast or splint) will be performed. Based on this randomized sequence, patients will then be treated with either a splint or a cast as they are enrolled into the study. 100 sealed envelopes will be marked 1-100 and a piece of paper stating either “cast” or “splint” will be placed inside each envelope as determined by the randomized sequence. These envelopes will be made by an independent person not involved in the study so that the order is not known to any of the treating physicians. The on call registrars enrolling patients will not know the method of treatment until patients have agreed to participate in the study and the envelope has been opened.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3159 0
New Zealand
State/province [1] 3159 0

Funding & Sponsors
Funding source category [1] 258394 0
Hospital
Name [1] 258394 0
Starship Childrens Hospital
Address [1] 258394 0
Department of Pediatric Orthopaedics
2 Park Road
Grafton
Auckland, New Zealand
1023
Country [1] 258394 0
New Zealand
Primary sponsor type
Hospital
Name
Starship Childrens Hospital
Address
Department of Pediatric Orthopaedics
2 Park Road
Grafton
Auckland, New Zealand
1023
Country
New Zealand
Secondary sponsor category [1] 257536 0
None
Name [1] 257536 0
Address [1] 257536 0
Country [1] 257536 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260368 0
Ethics committee address [1] 260368 0
Ethics committee country [1] 260368 0
Date submitted for ethics approval [1] 260368 0
25/10/2010
Approval date [1] 260368 0
Ethics approval number [1] 260368 0

Summary
Brief summary
The current standard of treatment following closed reduction of pediatric distal third radius fractures involves the placement of a well molded cast to maintain reduction. Casts provide rigid, circumferential immobilization. Because of the fixed diameter of the cast, there is minimal ability for the cast to accomodate fluctuations in soft tissue swelling that occurs after an acute injury. In the acute phase, casts can cause compression of neurovascular structures if wrapped too tightly. As the swelling resolves, the cast loses its ability to maintain fracture reduction due to a loss of contact between the cast material and the extremity. Studies have shown up to a 35% re-reduction rate in pediatric distal third radius fractures after manipulation and casting.

This study is designed to investigate if the application of a sugar tong splint with an elastic bandage immediately following closed reduction will lead to a decrease in the rereduction rate. A sugar tong splint with an elastic bandage is capable of accomodating changes in soft tissue swelling and should provide enough stability to maintain fracture reduction. The hypothesis is that the sugar tong splint will lead to a reduction in remanipulation rates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32136 0
Address 32136 0
Country 32136 0
Phone 32136 0
Fax 32136 0
Email 32136 0
Contact person for public queries
Name 15383 0
Kenneth Huh
Address 15383 0
Department of Pediatric Orthopaedics
2 Park Road
Grafton
Auckland, New Zealand
1023
Country 15383 0
New Zealand
Phone 15383 0
+64 (0)22 658 4355
Fax 15383 0
Email 15383 0
k_huh@hotmail.com
Contact person for scientific queries
Name 6311 0
Kenneth Huh
Address 6311 0
Department of Pediatric Orthopaedics
2 Park Road
Grafton
Auckland, New Zealand
1023
Country 6311 0
New Zealand
Phone 6311 0
022 658 4355
Fax 6311 0
Email 6311 0
k_huh@hotmail.com

No information has been provided regarding IPD availability
Summary results
No Results