Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Prolonged Immobilization (Casting)

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard of Care TreatmentActive comparator 1 intervention
Group B: Prolonged Immobilization (Casting)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bony Union

Ultrasound and radiographic images will be used to assess bony union. The images will be reviewed by a physician with expertise in assessing ultrasound to visualize the presence of bony bridging across the fracture site. This will be visualized as a hyperechoic line connecting the fracture piece to the donor bone.

Time frame
6-12 months

Secondary outcomes

1

Hospital for Special Surgery Pediatric Functional Activity Bried Scale (HSS Pedi-FABS)

Time frame
6-12 months
2

PROMIS Physical Activity

Time frame
6-12 months
3

PROMIS Mobility

Time frame
6-12 months
4

PROMIS Anxiety

Time frame
6-12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas Scottish Rite Hospital for Children

Lead sponsor

Source ClinicalTrials.gov
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