Casting Techniques for Elbow Fractures

Recruiting at 1 trial location

Overseen By Anthony Cooper, FRCSC

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Type II/III fracture, Neurovascular compromise, Bone disease

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

52 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{1 2 10 11 12}

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

Group I: Group 2 "Long-arm soft cast and no clinical or radiographic follow-up" Experimental Treatment 1 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 Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

Telemedicine is a feasible method for evaluating elbow range of motion in pediatric patients after long arm cast removal, showing no significant differences compared to in-office assessments.

In a study of 93 pediatric patients with an average immobilization time of 23 days, both remote and personal evaluations yielded similar results for elbow movements, suggesting telemedicine can effectively support follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of digital measurements for functional evaluation of paediatric elbow range of motion. Magno, GM., Fleman, C., Halliburton, C., et al.[2023]

In a study involving 47 children with forearm fractures, switching from a 6-week above-elbow cast (AEC) to a 3-week below-elbow cast (BEC) after 3 weeks resulted in similar limitations in arm movement after 6 months, indicating that early conversion to BEC is safe.

Both treatment methods showed comparable outcomes in terms of re-displacement, complications, and overall comfort, suggesting that the shorter treatment duration with BEC does not compromise recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Colaris, JW., Reijman, M., Allema, JH., et al.[2013]

In a study of 60 children aged 3 to 13 with forearm fractures, no cases of compartment syndrome or neurovascular injury were reported, indicating a high safety profile for the cast types used.

The type of cast (no valve, univalve, or bivalve) did not significantly affect complications, pain levels, or the need for further surgical intervention, suggesting that minimizing cast splitting could improve practice efficiency without compromising patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Valve or No Valve: A Prospective Randomized Controlled Trial of Casting Options for Pediatric Forearm Fractures. Baldwin, PC., Han, E., Parrino, A., et al.[2018]

Elbow fractures are a significant issue in children, making up 15% of all fractures, with a study analyzing 458,433 cases revealing that the average age of affected children is 7.4 years, predominantly boys (55.6%).

The study found that sports and recreation equipment is the leading cause of these fractures, especially in boys and children aged 8 and older, emphasizing the need for safe equipment use and parental guidance to prevent injuries from falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 10-Year National Analysis of Pediatric Elbow Fractures. Tom, JE., Eckhoff, MD., Tadlock, JC., et al.[2023]

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 6-wrap Softcast splint provides sufficient mechanical stability for treating unstable paediatric forearm fractures, with load capacities that exceed the forces exerted by body weight in many children.

Softcast splints are lighter, more comfortable, and can be easily removed compared to traditional plaster of Paris, making them a preferable option for younger patients while potentially reducing hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is softcast (3M) strong enough for potentially unstable paediatric forearm fractures? Patel, N., Wilson, L., Wansbrough, G.[2017]

The primary definitive cast technique (PDCT) using soft cast (SC) is significantly more cost-effective than the conventional plaster cast method (POPHC), with savings ranging from 138% to 336% depending on the type of cast.

Using PDCT with SC not only reduces costs but also enhances patient comfort, making it a beneficial option for fracture care in both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary definitive cast therapy on the upper and lower extremities. Indications and cost analysis]. Dresing, K., Schleikis, A., Stürmer, KM.[2021]

A long arm cast with the elbow extended is an effective technique for managing specific pediatric fractures, including proximal forearm fractures, olecranon fractures, flexion-type supracondylar fractures, and type II Monteggia fractures.

Timely diagnosis and treatment of these fractures are crucial to prevent complications, highlighting the importance of this casting technique in pediatric orthopedic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of a long arm extension cast in management of pediatric fractures: A technique revisited. Reynolds, AW., Hennrikus, WL., Adebayo, T., et al.[2020]

In a study of 86 pediatric patients with forearm fractures treated with extended elbow (EE) long-arm casts, only 4.7% required repeat interventions, indicating a significantly lower rate compared to historical data for flexed elbow (FE) casts, which had repeat intervention rates as high as 46%.

The use of EE casts resulted in no cases of malunion or nonunion, suggesting that this casting technique is both safe and effective for managing displaced, diaphyseal forearm fractures in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Quality in the Treatment of Pediatric Forearm Fractures: Minimizing the Need for Repeat Intervention With Long-arm Extension Casting. Neal, KM., Osterbur, TA., Kiebzak, GM.[2021]

References

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

Treatment of ulnar shaft fractures: a prospective, randomized study. [2022]

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

A Removable Long-arm Soft Cast to Treat Nondisplaced Pediatric Elbow Fractures: A Randomized, Controlled Trial. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Usefulness of digital measurements for functional evaluation of paediatric elbow range of motion. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

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]

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

Valve or No Valve: A Prospective Randomized Controlled Trial of Casting Options for Pediatric Forearm Fractures. [2018]

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

A 10-Year National Analysis of Pediatric Elbow Fractures. [2023]

8. Belgium pubmed.ncbi.nlm.nih.gov

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

Is softcast (3M) strong enough for potentially unstable paediatric forearm fractures? [2017]

10. Germany pubmed.ncbi.nlm.nih.gov

[Primary definitive cast therapy on the upper and lower extremities. Indications and cost analysis]. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Utility of a long arm extension cast in management of pediatric fractures: A technique revisited. [2020]

12. United States pubmed.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]