Lateral Ankle Treatment
ConditionAvulsion Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorTexas Scottish Rite Hospital for Children
About this trial
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
Qualifiers
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
Disqualifiers
Previous ipsilateral ankle surgery
Pre-existing musculoskeletal disease
If patient has been casted prior to confirmation of avulsion fracture on imaging
Developmental delay
Trial design
Treatments tested in this trial
- Prolonged Immobilization (Casting)
- Standard of Care (SOC)
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov