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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04642807




Registration number
NCT04642807
Ethics application status
Date submitted
18/11/2020
Date registered
24/11/2020
Date last updated
1/11/2022

Titles & IDs
Public title
Management of Type 1 Supracondylar Humeral Fractures
Scientific title
Management of Type 1 Supracondylar Humeral Fractures: A Multicentre Randomized Control Trial
Secondary ID [1] 0 0
H20-02942
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elbow Fracture 0 0
Trauma 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Long arm soft cast
Treatment: Surgery - Long arm full cast

Active Comparator: Group 1 "Long-arm full cast and routine follow-up" - Patients assigned to Group 1 will be placed in a long arm cast, at 90-100 degrees in neutral rotation. A referral will then be made to the orthopedic department and the patient reviewed at week 3 with cast removal, clinical assessment and radiographic assessment as determined by the normal practice at the local center.

Experimental: Group 2 "Long-arm soft cast and no clinical or radiographic follow-up" - Patients assigned to group 2 will be placed in a long arm cast at 90-100 degrees in neutral rotation. They will be given verbal and written information on the injury, when and how to remove the cast and contact details if there are any concerns.
Since they will not be attending clinical follow-up, an email or telephone survey will be undertaken at 3 weeks and after 6 months. The survey will inquire initially about pain, unplanned returns to the Family Physician and hospital, complications, parent/patient satisfaction and a standardized patient reported outcome score will be taken. Please see attached documentation for the itemized survey questions. The 6 month follow-up will include photographs and an illustrated guide will be given to the families on how to obtain pictures of maximal flexion, extension and the child's carrying angle (attached). Measurements of range of motion from photographs are considered comparable to clinical assessment of range of motion


Treatment: Surgery: Long arm soft cast
Participants in group 2 will have a long arm soft cast applied without clinical or radiological follow up.

Treatment: Surgery: Long arm full cast
Participants in group 1 will have a long arm full cast applied.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Faces Pain Scale - Revised (FPS-R)
Timepoint [1] 0 0
3 weeks post fracture
Secondary outcome [1] 0 0
Number of unplanned visits to the hospital or family physician
Timepoint [1] 0 0
During cast treatment
Secondary outcome [2] 0 0
Is parental satisfaction higher when they are empowered to remove a splint at home and follow a physician directed treatment program?
Timepoint [2] 0 0
3 Weeks post fracture
Secondary outcome [3] 0 0
Is there a difference in range of elbow joint motion between the two groups at 6 months post fracture?
Timepoint [3] 0 0
6 months post fracture
Secondary outcome [4] 0 0
• Is the difference in carrying angle from the contralateral arm at 6 months post fracture similar in children undergoing no clinical follow up or radiographic follow up compared to children undergoing routine follow-up as per the standard of care?
Timepoint [4] 0 0
6 months post fracture

Eligibility
Key inclusion criteria
- Children 3 to 8 years of age with a diagnosed supracondylar humerus fracture Type 1
(undisplaced).
Minimum age
3 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Children diagnosed with a Type II or III supracondylar fracture or any other elbow
injury

- Children who present with neurovascular compromise associated with their fracture

- Children who have been previously diagnosed with a metabolic or structural bone
disease that predisposes them to fractures

Diagnostic criteria for a Type I supracondylar fracture will include either:

A) A clear fracture line through the supracondylar region with no displacement or
angulation of the distal humerus (including a normal anterior humeral line that intersects
the capitellum) OR B) The absence of a clear fracture line but history of an extension
injury to the arm AND tenderness at the elbow AND local swelling AND presence of a
posterior fat pad on plain radiographs.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Queensland Children's Hospital, 501 Stanley Street, - South Brisbane
Recruitment postcode(s) [1] 0 0
QLD 4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia

Funding & Sponsors
Primary sponsor type
Other
Name
University of British Columbia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland Children's Hospital, South Brisbane
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study compares the clinical outcomes of treating pediatric Type 1 supracondylar fracture
with a long arm soft cast and no clinical or radiographic follow-up versus the standard
treatment in a long arm cast with clinical follow-up.

This is the first multicenter randomized control trial looking at the clinical effectiveness,
safety and parental satisfaction of managing inherently stable Type I supracondylar fractures
without clinical or radiological follow-up. If found to be safe; children can be managed
effectively without in-person follow-up, freeing clinic appointments to children on the
waiting list and in these COVID times avoiding unnecessary contacts.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04642807
Trial related presentations / publications
Silva M, Sadlik G, Avoian T, Ebramzadeh E. A Removable Long-arm Soft Cast to Treat Nondisplaced Pediatric Elbow Fractures: A Randomized, Controlled Trial. J Pediatr Orthop. 2018 Apr;38(4):223-229. doi: 10.1097/BPO.0000000000000802.
Witney-Lagen C, Smith C, Walsh G. Soft cast versus rigid cast for treatment of distal radius buckle fractures in children. Injury. 2013 Apr;44(4):508-13. doi: 10.1016/j.injury.2012.11.018. Epub 2012 Dec 22.
Shrader MW. Pediatric supracondylar fractures and pediatric physeal elbow fractures. Orthop Clin North Am. 2008 Apr;39(2):163-71, v. doi: 10.1016/j.ocl.2007.12.005.
Beaty JH and Kasser JR. The Elbow Region: General Concepts in the Pediatric Patient. In: Beaty JH and Kasser JR (editors). 6th ed. Philadelphia: Lippincott, Williams & Wilkins; 2006.
Wilkins KE and Rockwood CA. Fractures and Dislocations of the Elbow Region. 4th ed. Philadelphia: Lippincott-Raven; 1996.
GARTLAND JJ. Management of supracondylar fractures of the humerus in children. Surg Gynecol Obstet. 1959 Aug;109(2):145-54. No abstract available.
Barton KL, Kaminsky CK, Green DW, Shean CJ, Kautz SM, Skaggs DL. Reliability of a modified Gartland classification of supracondylar humerus fractures. J Pediatr Orthop. 2001 Jan-Feb;21(1):27-30. doi: 10.1097/00004694-200101000-00007.
Skaggs DL, Mirzayan R. The posterior fat pad sign in association with occult fracture of the elbow in children. J Bone Joint Surg Am. 1999 Oct;81(10):1429-33. doi: 10.2106/00004623-199910000-00007.
Symons S, Rowsell M, Bhowal B, Dias JJ. Hospital versus home management of children with buckle fractures of the distal radius. A prospective, randomised trial. J Bone Joint Surg Br. 2001 May;83(4):556-60. doi: 10.1302/0301-620x.83b4.11211.
Meislin MA, Wagner ER, Shin AY. A Comparison of Elbow Range of Motion Measurements: Smartphone-Based Digital Photography Versus Goniometric Measurements. J Hand Surg Am. 2016 Apr;41(4):510-515.e1. doi: 10.1016/j.jhsa.2016.01.006. Epub 2016 Feb 13.
Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.
Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.
Tsze DS, Hirschfeld G, von Baeyer CL, Bulloch B, Dayan PS. Clinically significant differences in acute pain measured on self-report pain scales in children. Acad Emerg Med. 2015 Apr;22(4):415-22. doi: 10.1111/acem.12620. Epub 2015 Mar 13.
Francis Ruvuna. Unequal Center Sizes, Sample Size, and Power in Multicenter Clinical Trials. Drug Inf 2004;38:387-94.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Harpreet Chhina, MSc
Address 0 0
Country 0 0
Phone 0 0
604-875-2000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04642807