52 Participants Needed

Casting Techniques for Elbow Fractures

Recruiting at 1 trial location
HC
AC
Overseen ByAnthony Cooper, FRCSC
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Long arm full cast and Long arm soft cast for elbow fractures?

The study on nondisplaced pediatric elbow fractures suggests that a long-arm soft cast can provide similar outcomes to a traditional long-arm hard cast, indicating that both types of casts may be effective for immobilizing elbow fractures.12345

Is casting for elbow fractures generally safe in humans?

Research on casting techniques for forearm fractures in children shows no significant safety concerns, such as neurovascular injury or compartment syndrome, associated with different casting methods. This suggests that casting, including long arm casts, is generally safe for use in humans.36789

How does the long arm soft cast treatment differ from other treatments for elbow fractures?

The long arm soft cast is unique because it is made from a semirigid material that combines fiberglass and polyurethane resin, allowing for a removable and potentially more comfortable option compared to traditional hard casts. This treatment is particularly useful for nondisplaced pediatric elbow fractures, offering similar outcomes to hard casts while being easier to manage.12101112

Eligibility Criteria

This trial is for children aged 3 to 8 with a specific type of elbow fracture (Type 1 supracondylar humerus fracture) that doesn't involve bone displacement. Kids must have symptoms like arm tenderness, swelling, and certain signs on an X-ray. Those with nerve/blood vessel damage, bone diseases, or more severe fractures are excluded.

Inclusion Criteria

My child, aged 3-8, has a Type 1 supracondylar humerus fracture.
I have a specific type of elbow injury, with or without a visible fracture but with certain symptoms and X-ray findings.

Exclusion Criteria

My child has a fracture affecting their nerves or blood flow.
My child has a severe elbow fracture.
My child was diagnosed with a bone condition that makes them more likely to break bones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a long arm cast, with Group 1 receiving routine follow-up and Group 2 receiving no clinical or radiographic follow-up

3 weeks
1 visit (in-person) for Group 1, no in-person visits for Group 2

Follow-up

Participants are monitored for safety and effectiveness after treatment via surveys and photographs

6 months
2 surveys (email or telephone) at 3 weeks and 6 months

Treatment Details

Interventions

  • Long arm full cast
  • Long arm soft cast
Trial Overview The study compares two treatments for stable elbow fractures in kids: one uses a soft cast without follow-up visits or X-rays; the other uses a traditional full cast with regular check-ups. It aims to see if avoiding clinic visits affects healing and satisfaction.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 "Long-arm soft cast and no clinical or radiographic follow-up"Experimental Treatment1 Intervention
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
Group II: Group 1 "Long-arm full cast and routine follow-up"Active Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Queensland Children's Hospital, South Brisbane

Collaborator

Trials
1
Recruited
50+

Findings from Research

In a randomized study of 31 patients with isolated ulnar shaft fractures, there was no significant difference in the time to union between long arm plaster immobilization, short arm plaster immobilization, and Ace Wrap bandage treatments.
The study found that 70% of patients treated with Ace Wrap failed due to pain and required conversion to plaster immobilization, and those in the Ace Wrap group had significantly greater angulation compared to the long arm cast group, suggesting that short arm casting for 8 weeks is the recommended treatment.
Treatment of ulnar shaft fractures: a prospective, randomized study.Atkin, DM., Bohay, DR., Slabaugh, P., et al.[2022]
A study involving 100 children with nondisplaced elbow fractures found that a removable long-arm soft cast is as effective as a traditional hard cast in maintaining fracture alignment and achieving similar recovery outcomes.
Both cast types resulted in comparable range of motion, pain levels, and high patient satisfaction, suggesting that soft casts could reduce healthcare visits and costs while improving compliance.
A Removable Long-arm Soft Cast to Treat Nondisplaced Pediatric Elbow Fractures: A Randomized, Controlled Trial.Silva, M., Sadlik, G., Avoian, T., et al.[2022]
A study involving patients over 55 years with stable distal radius fractures found that short arm plaster casts are as effective as long arm casts in terms of functional outcomes and radiological parameters, except for minor differences in volar tilt.
Patients with long arm casts experienced significantly higher disability and shoulder pain compared to those with short arm casts, suggesting that short arm casts are a more comfortable option that allows for better daily activity engagement.
Is a short arm cast appropriate for stable distal radius fractures in patients older than 55 years? A randomized prospective multicentre study.Park, MJ., Kim, JP., Lee, HI., et al.[2022]

References

Treatment of ulnar shaft fractures: a prospective, randomized study. [2022]
A Removable Long-arm Soft Cast to Treat Nondisplaced Pediatric Elbow Fractures: A Randomized, Controlled Trial. [2022]
Is a short arm cast appropriate for stable distal radius fractures in patients older than 55 years? A randomized prospective multicentre study. [2022]
Usefulness of digital measurements for functional evaluation of paediatric elbow range of motion. [2023]
Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial. [2013]
Valve or No Valve: A Prospective Randomized Controlled Trial of Casting Options for Pediatric Forearm Fractures. [2018]
A 10-Year National Analysis of Pediatric Elbow Fractures. [2023]
Extension Casting For Both-Bone Forearm Fractures In Children. [2019]
Is softcast (3M) strong enough for potentially unstable paediatric forearm fractures? [2017]
[Primary definitive cast therapy on the upper and lower extremities. Indications and cost analysis]. [2021]
Utility of a long arm extension cast in management of pediatric fractures: A technique revisited. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Improving Quality in the Treatment of Pediatric Forearm Fractures: Minimizing the Need for Repeat Intervention With Long-arm Extension Casting. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security