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Recruiting
NCT07751068
Lateral Ankle Treatment
Conditions: Avulsion Fracture
Sex: All
Ages: 5 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Texas Scottish Rite Hospital for Children
Location: Texas Scottish Rite Hospital for Children Frisco Texas
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07751068). StuddyBuddy aggregates publicly available trial information.