Cast Positioning for Broken Arm

Overseen By Elizabeth C Marks, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Metabolic bone disease, open fractures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of cast better aids healing in broken forearms for children and teens. It compares two cast types: one that keeps the elbow straight and another that keeps it bent. The study targets children aged 3-18 with a specific type of broken arm requiring a cast for healing. Children with both forearm bones broken who need a cast may qualify for this trial. As an unphased study, it offers an opportunity to contribute to valuable research that could enhance treatment options for young patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these immobilization methods are safe for children with forearm fractures?

Research has shown that both types of casts—those that keep the elbow straight (extension) and those that bend it (flexion)—are generally safe for treating broken arms in children. Studies have found that long arm casts, which cover the elbow, help prevent unwanted movement, keeping the broken bones in place and reducing the risk of further injury. However, if a cast doesn't fit well, it can sometimes cause skin sores or discomfort.

Switching to a shorter cast after a few weeks for casts that bend the elbow is also considered safe and can increase the child's comfort. Ensuring the child's comfort in their cast is important, and any ongoing pain should be discussed with a doctor. Overall, evidence suggests that both types of casts are well-tolerated by children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on cast positioning for broken arms because it explores how different arm positions during casting might affect healing. Unlike standard treatments that often standardize cast positioning, this trial investigates the benefits of elbow flexion versus elbow extension in long arm casts. This could lead to insights on optimizing recovery time and improving patient comfort, making it a potentially significant advancement in treating broken arms.

What evidence suggests that this trial's treatments could be effective for broken arms?

This trial will compare two casting methods for broken arms: the Elbow Extension Cast and the Elbow Flexion Cast. Research has shown that long arm extension casts work well for children with fractures in the upper forearm, maintaining proper bone alignment. When comparing casting with the elbow bent to casting with the elbow straight, studies suggest that straight casting might be more effective, especially when performed by less experienced doctors. Both methods have demonstrated similar long-term results for stable fractures. Thus, both approaches can be effective, but the choice might depend on specific factors, such as the skill of the person applying the cast. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 3-18 with a specific type of broken arm where both the radius and ulna bones are fractured in the upper half. They must need reduction (realignment) and casting, but can't join if they have fractures in other locations, isolated bone fractures, metabolic bone diseases, or certain other conditions.

Inclusion Criteria

I have fractures in both my radius and ulna bones in the upper half of my arm.

I am between 3 and 18 years old.

My bones are still growing.

Exclusion Criteria

Deformity or abnormality not allowing for standard casting (limb deficiency, contracture)

I have a specific type of arm fracture.

My parent speaks a language other than English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive either an elbow extension or flexion cast

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cast

Trial Overview The study is testing two different ways to immobilize a child's arm after a fracture: one using an elbow extension cast and the other using an elbow flexion cast. The goal is to see which method leads to better healing outcomes.

How Is the Trial Designed?

Group I: Elbow Flexion Cast Experimental Treatment 1 Intervention

This cohort will be placed in a long arm flexion cast.

Group II: Elbow Extension Cast Experimental Treatment 1 Intervention

This cohort will be placed in a long arm extension cast.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of 189 pediatric patients with both-bone forearm fractures, casting technique did not significantly affect failure rates, indicating that various methods can be used effectively.

However, when casting was performed by trainees, using an extension casting technique significantly reduced failure rates, suggesting that this method may enhance safety and efficacy for less experienced practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extension Casting For Both-Bone Forearm Fractures In Children. Babazadeh, S., Mason, TG., Petterwood, J., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Distal forearm fractures are the most common childhood fractures, and children often experience significant pain after being discharged from the Emergency Department.

This study aims to compare the pain levels in children treated with short casts versus long casts after a distal forearm fracture reduction, hypothesizing that long casts will result in less pain in the first 48 hours post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short and long arm cast and pain after discharge in children who underwent reduction of distal forearm fracture in the Emergency Department: A study protocol for a randomized comparative effectiveness study. Giacalone, M., Capua, T., Shavit, I.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10821167/

External fixation about the elbow: Indications and long-term ... The use of external fixation about the elbow is associated with significantly worse initial injuries and results in poorer outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10242373/

Below- versus above-elbow cast treatment of displaced ... Loss of fracture reduction was noted in 28.9% of patients treated with above-elbow cast and 21.5% in below-elbow cast. Re-manipulation was ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352644018300256

Utility of a long arm extension cast in management ... Case series have been published that report excellent results for children casted with elbow in extension after sustaining both proximal and middle one-third ...

4. e-emj.org e-emj.org/journal/view.php?doi=10.12771/emj.2024.e51

Comparison of the long-term outcomes of cast ... Conclusion: In stable fractures treated conservatively, the use of both short and long arm casts resulted in comparable functional outcomes in older patients.

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-019-1530-1

Below-elbow or above-elbow cast for conservative treatment ... In support of this approach, they published an article in which they stated that they had achieved good-to-excellent results in 82% of patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3822135/

Conversion to below-elbow cast after 3 weeks is safe for ... Early conversion to BEC cast is safe and results in greater cast comfort. Most displaced diaphyseal both-bone forearm fractures in children can be treated ...

7. medicaljournalssweden.se medicaljournalssweden.se/JPHS/article/download/12200/15943

Cast selection and non-union rates for acute scaphoid ... In our study, short arm casting was proven non-inferior to long arm casting. Similarly, casts without thumb immobilization were equally as effective as casts ...

8. withpower.com withpower.com/trial/phase-radius-fractures-7-2022-b13ba

Cast Positioning for Broken Arm · Info for Participants Studies indicate that both short and long arm casts can maintain the position of the fracture, with long casts potentially reducing pain after discharge.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12093553/

Comparison of the long-term outcomes of cast immobilization ... In these cases, it is believed that the long arm cast prevents elbow motion and forearm rotation, minimizing the risk of fracture displacement. However, this ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2768276525000884

Common Cast Complications Poor cast molding can lead to skin sores and loss of fracture reduction. (4). Patients should be comfortable in their cast, and uncontrolled pain warrants ...