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Avulsion FractureNCT07751068

Lateral Ankle Treatment

A study testing Prolonged Immobilization (Casting) in people with Avulsion Fracture, run by Texas Scottish Rite Hospital for Children at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Avulsion Fracture
What is being tested?
Prolonged Immobilization (Casting)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
8 Jun 2026to 1 Apr 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Wilhelmy, MS contact

469-857-21109

anna.wilhelmy@tsrh.org

Robert Van Pelt, MPH contact

214-559-7456

bobby.vanpelt@tsrh.org

United States1 site, 1 recruiting
  • Texas Scottish Rite Hospital for Children

    Frisco, Texas, 75034

    Anna Wilhelmy, MS, 469-857-2109, anna.wilhelmy@tsrh.org

    Jacob Jones, MD

    Recruiting

Other trials in United States

About this study

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

Read the detailed description

This is a randomized control trial for pediatric patients who present to Scottish Rite for an acute lateral ankle avulsion fracture. Patients will be randomized into standard of care treatment or prolonged immobilization (test treatment). Standard of care treatment is booting with early range of motion or test treatment and gradually weaning from the boot. Test treatment (prolonged immobilization) is 6 weeks of immobilization in the form of a short-leg cast. The purpose is to see if prolonged immobilization will promote healing of the avulsion fracture and prevent the formation of a subfibular ossicle which occurs 100% of the time in standard of care treatment based upon our previous study. Patients will follow-up for a single visit between 6- and 12-months post enrollment for repeat imaging to assess for the formation/prevention of a subfibular ossicle. These visits will include an ultrasound and radiographs. Secondary outcomes include evaluation of function based upon PROs and biomechanical testing in the movement science lab at the follow-up visit. Enrolled patients may also be contacted for injury surveillance and PROs for up to 5 years following RTP.

Treatment Groups:

  1. Standard of Care Treatment: 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.
  2. 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.

Visits:

Visit 0:

This visit will occur at the time of the diagnosis and enrollment. All patients that have evidence of an avulsion fracture either on radiographs and/or ultrasound that meet inclusion criteria will be asked to enroll. Patients will undergo standard ankle radiographs as part of the standard of care.

Patients will also undergo a standard of care ultrasound including scanning of the lateral ankle to evaluate for radiographically-silent avulsion fracture. Treatment will be randomized. Patients or parent/LAR will be asked to fill out patient-reported outcomes (PROs) that include the HSS PediFABS, Oxford Ankle Foot Questionnaire for Children and PROMIS Physical Activity, Mobility, and Anxiety. Investigators will also collect demographics and injury related information from the medical record.

Visit 1 (Research Only Visit):

This will occur at 6-12 months post enrollment (4-16 months window). At this time, the patient and/or parent will fill out the same PROs as Visit 0. These patients will undergo repeat ankle ultrasound and radiographs to evaluate for continued avulsion healing verses early subfibular ossicle development. Radiographs are considered the standard of care for subfibular ossicle development. Ultrasound provides a non-radiating way to assess for and measure a subfibular ossicle in 3 dimensions. This will help see if one has developed and to see the size. Patients will also undergo biomechanical and pedobarography testing in the movement science lab to compare biomechanical differences between the two different test groups. During motion analysis testing, small reflective markers will be placed on the participants' feet, legs, arms, torso and head and electromyography sensors may be placed on the participant's legs. Markers and sensors will be held in place with tape to assure their placement during motion analysis. A subject calibration will be completed using the computer motion capture system while the participant stands quietly for approximately 1 minute. Following calibration, the participant will be asked to walk back and forth across the room along a 10m walkway until an appropriate number of clean data collections are completed (~10 walks). Participants may also be asked to walk at different speeds, jog, run, and perform other functional tasks including, but not limited to: accelerating/decelerating, cutting, drop landing, jumping, drop vertical jump, unilateral or bilateral limb squats, and/or sport specific movements. Participants will be given seated rest periods as necessary. Full body or lower extremity kinematics, kinetics, muscle activity and whole body center of mass will be determined for all activities. Subjects may be asked to complete these tasks barefoot or with shoes. Subjects may be asked to complete testing with or without ankle orthoses, as applicable. Participants will undergo motion analysis for research purposes only.

Bilateral strength testing of ankle (dorsiflexion/plantar flexion, inversion/eversion) muscle groups may be performed. The patient will perform two practice repetitions, followed by five recorded maximal effort repetitions, and may be conducted either isometrically or isokinetically. Maximal peak torque will be reported. Participants will undergo strength testing for research purposes only.

Plantar pressures may be collected one or two ways: 1) the participant may be asked to walk across a pressure plate (pedobarograph) embedded in the floor, or 2) foot pressures may be recorded via sensors placed within the participant's shoes. Both sensors (floor or in-shoe) provide a foot-print image of pressure under the foot, and it is collected dynamically at 50 to 240Hz.

Variables may include but are not limited to the peak pressure, maximal force, pressure-time integral, contact area and contact time of the entire foot, as well as within the different regions of the foot

Being tested
Prolonged Immobilization (Casting), Standard of Care (SOC)
Keywords
Avulsion Fracture, subfibular ossicle, Lateral ankle, short-leg cast
Medical subject headings
Fractures, Avulsion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolonged Immobilization (Casting)Procedure or 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 or 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.

Study groups in NCT07751068
Study groupRoleWhat they receive
Standard of Care TreatmentActive comparatorNot described
Receives: Procedure: Standard of Care (SOC)
Prolonged Immobilization (Casting)ExperimentalNot described
Receives: Procedure: Prolonged Immobilization (Casting)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-12 months

Secondary outcomes (5)
  1. Hospital for Special Surgery Pediatric Functional Activity Bried Scale (HSS Pedi-FABS)

    Measured: 6-12 months

  2. PROMIS Physical Activity

    Measured: 6-12 months

  3. PROMIS Mobility

    Measured: 6-12 months

  4. PROMIS Anxiety

    Measured: 6-12 months

  5. Oxford Ankle Foot Questionnaire for Children

    Measured: 6-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study start8 Jun 2026
  3. Primary completion1 Apr 2032 (estimated)
  4. Study completion1 Apr 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07751068
Sponsor's protocol ID
STU20251534
Status last verified
Aug 2026
First submitted
28 May 2026
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be shared following publication of the primary study results. Requests for data access can be submitted to Jacob Jones, MD at Texas Scottish Rite Sports Medicine Department starting 6 months after publication, and data will be available for a period of 24 months. De-identified participant data and data dictionaries will be shared. Access will be granted to researchers with appropriate IRB/ethics approval and who have executed a data use agreement with the sponsor.

Publications

  • Beynnon BD, Renstrom PA, Haugh L, Uh BS, Barker H. A prospective, randomized clinical investigation of the treatment of first-time ankle sprains. Am J Sports Med. 2006 Sep;34(9):1401-12. doi: 10.1177/0363546506288676. Epub 2006 Jun 26.

    PubMed 16801691
  • Le Gall F, Carling C, Reilly T. Injuries in young elite female soccer players: an 8-season prospective study. Am J Sports Med. 2008 Feb;36(2):276-84. doi: 10.1177/0363546507307866. Epub 2007 Oct 11.

    PubMed 17932408
  • Pill SG, Hatch M, Linton JM, Davidson RS. Chronic symptomatic os subfibulare in children. J Bone Joint Surg Am. 2013 Aug 21;95(16):e115(1-6). doi: 10.2106/JBJS.L.00847.

    PubMed 23965709
  • Prado MP, Mendes AA, Amodio DT, Camanho GL, Smyth NA, Fernandes TD. A comparative, prospective, and randomized study of two conservative treatment protocols for first-episode lateral ankle ligament injuries. Foot Ankle Int. 2014 Mar;35(3):201-6. doi: 10.1177/1071100713519776. Epub 2014 Jan 13.

    PubMed 24419825
  • Yamaguchi S, Akagi R, Kimura S, Sadamasu A, Nakagawa R, Sato Y, Kamegaya M, Sasho T, Ohtori S. Avulsion fracture of the distal fibula is associated with recurrent sprain after ankle sprain in children. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2774-2780. doi: 10.1007/s00167-018-5055-7. Epub 2018 Jul 10.

    PubMed 29992464
  • Berg EE. The symptomatic os subfibulare. Avulsion fracture of the fibula associated with recurrent instability of the ankle. J Bone Joint Surg Am. 1991 Sep;73(8):1251-4.

    PubMed 1890128

Questions about this trial

What is this clinical trial studying?

A study testing Prolonged Immobilization (Casting) in people with Avulsion Fracture, run by Texas Scottish Rite Hospital for Children at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Wilhelmy, MS (469-857-21109, anna.wilhelmy@tsrh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bony Union (time frame: 6-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07751068, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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