Management of Type 1 Supracondylar Humeral Fractures

NCT04642807 | Recruiting

• 1 other identifier: H20-02942
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 2

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.

Conditions

Elbow Fracture; Trauma

Keywords

Supracondylar humeral fracture; Pediatric elbow fracture

Outcome Measures

Primary Outcomes (1)

• Faces Pain Scale - Revised (FPS-R)

  The Faces Pain Scale - Revised (FPS-R) will be used to measure pain score. The scale uses a 0 to 10 metric that is in close linear relationship with a visual analogue pain scale. 0 is no pain and 10 is very much pain.

  3 weeks post fracture

Secondary Outcomes (4)

• Number of unplanned visits to the hospital or family physician

  During cast treatment

• Is parental satisfaction higher when they are empowered to remove a splint at home and follow a physician directed treatment program?

  3 Weeks post fracture

• Is there a difference in range of elbow joint motion between the two groups at 6 months post fracture?

  6 months post fracture

• • 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?

  6 months post fracture

Study Arms (2)

Group 1 "Long-arm full cast and routine follow-up"

ACTIVE COMPARATOR

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.

Procedure: Long arm full cast

Group 2 "Long-arm soft cast and no clinical or radiographic follow-up"

EXPERIMENTAL

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

Procedure: Long arm soft cast

Interventions

Long arm soft cast PROCEDURE

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

Group 2 "Long-arm soft cast and no clinical or radiographic follow-up"

Long arm full cast PROCEDURE

Participants in group 1 will have a long arm full cast applied.

Group 1 "Long-arm full cast and routine follow-up"

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Children 3 to 8 years of age with a diagnosed supracondylar humerus fracture Type 1 (undisplaced).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Queensland Children's Hospital: collaborator

Study Sites (2)

Queensland Children's Hospital, 501 Stanley Street,

South Brisbane, QLD 4101, Australia

RECRUITING

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Related Publications (14)

• 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.

  PMID: 29517983 BACKGROUND

• 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.

  PMID: 23265786 BACKGROUND

• 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.

  PMID: 18374807 BACKGROUND

• 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.

  BACKGROUND

• Wilkins KE and Rockwood CA. Fractures and Dislocations of the Elbow Region. 4th ed. Philadelphia: Lippincott-Raven; 1996.

  BACKGROUND

• GARTLAND JJ. Management of supracondylar fractures of the humerus in children. Surg Gynecol Obstet. 1959 Aug;109(2):145-54. No abstract available.

  PMID: 13675986 BACKGROUND

• 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.

  PMID: 11176349 BACKGROUND

• 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.

  PMID: 10535592 BACKGROUND

• 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.

  PMID: 11380131 BACKGROUND

• 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.

  PMID: 26880499 BACKGROUND

• 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.

  PMID: 11427329 BACKGROUND

• 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.

  PMID: 20921070 BACKGROUND

• 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.

  PMID: 25773461 BACKGROUND

• Francis Ruvuna. Unequal Center Sizes, Sample Size, and Power in Multicenter Clinical Trials. Drug Inf 2004;38:387-94.

  BACKGROUND

MeSH Terms

Conditions

Elbow Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Fractures, Bone

Central Study Contacts

Harpreet Chhina, MSc

CONTACT

604-875-2000; hchhina@cw.bc.ca

Anthony Cooper, FRCSC

CONTACT

604-875-2000; externalfixators@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: April 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CA (1)