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RECRUITING
NCT07751068
NA

Lateral Ankle Treatment

Sponsor: Texas Scottish Rite Hospital for Children

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

5 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-08

Completion Date

2034-04-01

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

PROCEDURE

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.

PROCEDURE

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.

Locations (1)

Texas Scottish Rite Hospital for Children

Frisco, Texas, United States