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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.

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 data supports the effectiveness of the treatment Cast for broken arms?

Research shows that using a cast to immobilize forearm fractures in children is effective, especially when the cast is applied correctly to prevent movement. Studies indicate that both short and long arm casts can maintain the position of the fracture, with long casts potentially reducing pain after discharge. ^{1 2 3 4 5}

Is cast positioning for broken arms generally safe for humans?

Casts are generally safe for immobilizing broken bones, but there can be complications like thermal injuries (burns from heat) and discomfort, especially with long arm casts. Proper patient information and careful application can help prevent these issues. ^{3 4 5 6 7}

How does the cast positioning treatment for a broken arm differ from other treatments?

This treatment focuses on the position of the wrist and forearm in the cast, which can affect the outcome of healing. Research suggests that certain positions, like pronation, may reduce the chance of the bone moving out of place again compared to other positions. ^{8 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Utility of the Three-Point Index in the determination of reduction loss during the conservative treatment of pediatric forearm mid-third fractures. [2019]

2. Sweden pubmed.ncbi.nlm.nih.gov

Cast and padding indices used for clinical decision making in forearm fractures in children. [2016]

3. Belgium pubmed.ncbi.nlm.nih.gov

Extension Casting For Both-Bone Forearm Fractures In Children. [2019]

4. Netherlands 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. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of patient information concerning casts applied post-fracture. [2015]

6. England 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Thermal injury with contemporary cast-application techniques and methods to circumvent morbidity. [2016]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Where to split plaster casts. [2005]

9. Germany pubmed.ncbi.nlm.nih.gov

Does position of the wrist during cast immobilisation in patients with distal radius fractures affect outcome? [2022]

10. England pubmed.ncbi.nlm.nih.gov

Treatment of Colles' fracture. A prospective comparison of three different positions of immobilization. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of pressure beneath a split above elbow plaster cast. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

A method of pediatric short arm cast application. [2005]