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Lateral Ankle Treatment

NCT07751068 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Texas Scottish Rite Hospital for Children

    lead OTHER

Principal Investigators

  • Jacob Jones, MD · Scottish Rite for Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2032-04-01
Completion
2034-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751068 on ClinicalTrials.gov