Lateral Ankle Treatment

Conditions

• Avulsion Fracture

Eligibility Criteria

Sex

ALL

Age

5 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Prolonged Immobilization (Casting) — PROCEDURE
  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) — PROCEDURE
  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.

Study Details

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.

Key Dates

First listed

Aug 7, 2026

Start date

Jun 8, 2026

Status verified

Aug 2026

Primary completion

Apr 1, 2032

Completion

Apr 1, 2034

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Standard of Care Treatment
• Experimental: Prolonged Immobilization (Casting)

Primary Outcome Measure

Bony Union [ Time Frame: 6-12 months ]

Central Contacts

• Anna Wilhelmy, MS
  469-857-21109
  [email protected]
• Robert Van Pelt, MPH
  214-559-7456
  [email protected]

Locations (1)

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