Clinical trial Recruiting at 1 site Interventional Ages 5 to 12

Lateral Ankle Avulsion Fracture in Children: Casting vs Boots

Official title: Prevention of the Os Fibulare After an Acute Lateral Ankle Avulsion Fracture in Pediatric Patients: A Randomized Control Trial

Run by Texas Scottish Rite Hospital for Children · NCT07751068 · Data updated 2026-11-12

In kids with a first-time lateral ankle avulsion fracture, we’re testing whether 6 weeks in a cast gives better healing and fewer bone spurs than standard booting with early movement.

Quick facts

Study typeInterventional
Ages5 Years to 12 Years
SexAll
Enrollment50 (estimated)
SponsorTexas Scottish Rite Hospital for Children
Academic / other
Locations1 site (Frisco, Texas)
StatusRecruiting
StartedJune 8, 2026
Main results expectedApril 1, 2032
Study endsApril 1, 2034
Registry record updatedOctober 30, 2026
Trial IDNCT07751068 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 5–12 with a first-time lateral ankle avulsion fracture confirmed by imaging and enrolled within 14 days of injury, who and whose guardians speak English or Spanish.

Probably not a fit

Patients whose injury heals well with standard care or who cannot tolerate casting may not experience added benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares two treatments for acute lateral ankle avulsion fractures in children aged 5–12. Participants are randomized to either standard care (boot with early range of motion and gradual return to activity) or prolonged immobilization with a short-leg cast for six weeks. Follow-up includes imaging at 6–12 months to look for a subfibular ossicle, plus functional PROs and biomechanical testing; long-term injury surveillance up to five years may occur. The study is conducted at Texas Scottish Rite Hospital for Children in Frisco, with eligibility limited to English or Spanish-speaking families and specific age/injury criteria.

Why it matters

Potential benefit: If casting proves beneficial, children may experience improved healing and reduced risk of subfibular ossicle development.

How similar studies have gone: Previous data suggest subfibular ossicle formation is common with standard care; this trial tests whether casting can prevent it.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Ages 5-12 at time of enrollment
* Diagnosis of first-time lateral ankle injury and an avulsion fracture visible on imaging who can be enrolled within 14 days of injury
* Patient and parent/legal guardian must speak English or Spanish

Exclusion Criteria:

* Previous ipsilateral ankle surgery
* Pre-existing musculoskeletal disease
* If patient has been casted prior to confirmation of avulsion fracture on imaging
* Developmental delay
* Does not meet inclusion criteria

Where it's running

  • Texas Scottish Rite Hospital for Children
    Frisco, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.