Recruiting

Casting & Booting

Sponsor:

Texas Scottish Rite Hospital for Children

Code:

NCT07751068

Conditions

Avulsion Fracture

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Prolonged Immobilization (Casting)

Standard of Care (SOC)

Study Details

Brief summary:

This is a randomized control trial of pediatric patients with acute lateral ankle avulsion fractures. Patients will be randomized into two groups: Standard of care treatment which includes booting with early range of motion and gradual weening from the boot and a Test treatment which includes a 6 week short-let cast. The purpose of the study is to test whether prolonged immobilization (casting) can help prevent the formation of a subfibular ossicle. The study consists of two patient visits.

Conditions

Avulsion Fracture

Study ID

NCT07751068

Start date

Jun 8, 2026

Status verified date

Aug, 2026

Completion date

Apr 1, 2034

Anticipated

Primary completion date

Apr 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Treatment

experimental: Prolonged Immobilization (Casting)

Interventions

Prolonged Immobilization (Casting)

Patients will be treated with a non-weightbearing short-leg cast for 6 weeks to promote avulsion fracture healing. This will be followed physical therapy, and a gradual return to activity.

Standard of Care (SOC)

Patients will receive brief immobilization (boot) as needed, followed by early range of motion exercises. Physical therapy and a return-to-activity plan will be implemented as symptoms allow.

Primary outcome measure

  • Bony Union [ Time Frame: 6-12 months ]

Central Contacts and Locations

Central contacts

Anna Wilhelmy, MS

469-857-21109anna.wilhelmy@tsrh.org

Robert Van Pelt, MPH

214-559-7456bobby.vanpelt@tsrh.org

Locations

Texas Scottish Rite Hospital for Children

Recruiting

Frisco, Texas, United States, 75034

Contacts

Anna Wilhelmy, MS

469-857-2109anna.wilhelmy@tsrh.org

Principal Investigator:

Jacob Jones, MD

More Information

Sponsor

Texas Scottish Rite Hospital for Children

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Avulsion Fracture
  • subfibular ossicle
  • Lateral ankle
  • short-leg cast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Scottish Rite Hospital for Children on 2026-08-07.