50 Participants NeededMy employer runs this trial

Prolonged Immobilization for Ankle Fractures

RV
AW
Overseen ByAnna Wilhelmy, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Texas Scottish Rite Hospital for Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether keeping a child's ankle in a cast for six weeks can prevent extra bone growth, known as a subfibular ossicle, after an ankle fracture. It compares this method to the usual treatment, which involves using a boot and gradually moving the ankle. The researchers seek children aged 5-12 who have recently experienced their first lateral ankle injury with an avulsion fracture confirmed by imaging. Participants should join the study within two weeks of their injury. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve future treatments for children with similar injuries.

What prior data suggests that prolonged immobilization (casting) is safe for pediatric patients with ankle fractures?

Research shows that using a cast is a common and usually safe way to treat broken bones. A cast keeps the bone still during healing, helping it align properly and heal well.

Studies indicate that most people tolerate casting well. Serious side effects are rare, but some might experience minor issues like skin irritation or discomfort from the cast. These problems are usually easy to manage and resolve quickly. Overall, casting is a widely trusted method for healing bones.12345

Why are researchers excited about this trial?

Researchers are excited about the treatment called Prolonged Immobilization (Casting) for ankle fractures because it explores the potential benefits of keeping the ankle in a cast longer than usual. Unlike the standard practice, which often involves a shorter period of immobilization followed by rehabilitation, this approach could promote better healing for certain types of fractures by preventing premature movement. The aim is to see if a longer casting period reduces complications and enhances recovery, which could be a game-changer for people with more severe or complex ankle injuries.

What evidence suggests that prolonged immobilization might be an effective treatment for ankle fractures?

Research has shown that immobilizing an ankle, such as with a cast, aids in healing ankle fractures. In this trial, participants may undergo prolonged immobilization through casting. One study found that wearing a cast for six weeks was as effective as surgery for healing unstable ankle fractures, with fewer risks. Other research has indicated that a cast provides strong support, promoting proper fracture healing. Casting also reduces pain shortly after surgery and lowers the risk of wound complications compared to treatments that involve early ankle movement. Overall, using a cast has demonstrated positive results in aiding ankle fracture recovery.678910

Who Is on the Research Team?

JJ

Jacob Jones, MD

Principal Investigator

Scottish Rite for Children

Are You a Good Fit for This Trial?

This trial is for children who have recently had a specific type of ankle fracture called an acute lateral ankle avulsion fracture. Participants must be able to attend two study visits and not have other conditions that would prevent them from following the treatment plan.

Inclusion Criteria

Patient and parent/legal guardian must speak English or Spanish
I have my first lateral ankle injury with an avulsion fracture seen on imaging within 14 days.
I am between 5 and 12 years old.

Exclusion Criteria

I have a musculoskeletal disease that I had before this trial.
Developmental delay
Does not meet inclusion criteria
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive either standard of care treatment with a boot or prolonged immobilization with a short-leg cast for 6 weeks

6 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat imaging and biomechanical testing

6-12 months
1 visit (in-person)

Long-term follow-up

Participants may be contacted for injury surveillance and patient-reported outcomes for up to 5 years following return to play

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Prolonged Immobilization (Casting)

Trial Overview

The study compares two treatments: one group gets standard care with a walking boot and early movement, while the other group has their ankle in a cast for six weeks. The goal is to see if casting better prevents bone growth problems near the injury.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Prolonged Immobilization (Casting)Experimental Treatment1 Intervention
Group II: Standard of Care TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Scottish Rite Hospital for Children

Lead Sponsor

Trials
23
Recruited
9,000+

Citations

Comparative efficacy of cast immobilization versus removable ...

This study concluded that the recovery rate after ankle fracture in adults approached 80% in the sixth month and reached stability in the 24th ...

Wound complications after cast immobilization compared ...

Conclusion. post-operative cast immobilization reduced the risk of wound complications compared to early functional treatment in skeletally mature patients ...

Optimizing Ankle Fracture Outcomes with Short-Term ...

Short-term cast immobilization after ankle fracture surgery can significantly reduce postoperative pain in the early stage, without increasing the recovery

Braces versus casts for post-operational immobilization of ...

Generally, cast immobilization is required for several weeks after an ankle fracture because the cast can provide maximum support for the fracture, promoting ...

Six week casting proves as effective as surgery for ...

Wearing a cast for six weeks appears to be no less effective than surgery for healing unstable ankle fractures and carries fewer treatment ...

Fracture | MedlinePlus

A fracture is a partial or complete break in the bone. There are different causes and types of fractures. Symptoms include intense pain, ...

Bone Fractures (Broken Bones): Types, Symptoms & ...

Bone fracture treatments include: Immobilization: You'll need a splint or cast to hold your bone in place while it heals. If you have a non ...

Risk factors for hip fracture in white women. Study of ... - PubMed

Women with multiple risk factors and low bone density have an especially high risk of hip fracture. Maintaining body weight, walking for exercise, ...

Bone fracture

By allowing only limited movement, immobilization helps preserve anatomical alignment while enabling callus formation, toward the target of achieving union.

Fractures

Treatment may include: Splint or cast. This immobilizes the injured area to keep the bone in alignment. It protects the injured area from motion or use while ...