ClinicalTrials.gg
RecruitingNCT07751068Updated Oct 30, 2026

Lateral Ankle Treatment

An interventional study of Prolonged Immobilization (Casting) and Standard of Care (SOC) in Avulsion Fracture, sponsored by Texas Scottish Rite Hospital for Children. Recruiting at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Texas Scottish Rite Hospital for Children · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

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.

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:

A) 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.

B) 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

02

Conditions studied

  • Avulsion Fracture

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Keywords

  • Avulsion Fracture
  • subfibular ossicle
  • Lateral ankle
  • short-leg cast
03

In context

Fractures, Avulsion

16 studies on the registry are indexed under Fractures, Avulsion; 4 are open to participants now.

Browse Fractures, Avulsion studies →

Lead sponsor

Texas Scottish Rite Hospital for Children is the lead sponsor of 18 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Standard of Care Treatment

    Procedure: Standard of Care (SOC)

  • Experimental
    Prolonged Immobilization (Casting)

    Procedure: Prolonged Immobilization (Casting)

Interventions

  • ProcedureProlonged 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.

  • ProcedureStandard 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.

06

What researchers measure

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)

    Indicates the activity level of participants with total scores ranging from 0-30; 0 points is the lowest measured activity level and 30 points is the highest measured activity level.

    Time frame: 6-12 months

  2. PROMIS Physical Activity

    Lowest possible score is 10 points, highest possible score is 50 points. The higher the score, the more physical activity the participant is engaging in.

    Time frame: 6-12 months

  3. PROMIS Mobility

    Highest possible score is 50 points, lowest possible score is 10 points. The higher the score, the better mobility the patient has.

    Time frame: 6-12 months

  4. PROMIS Anxiety

    Highest possible score is 50 points, lowest possible score is 10. The higher the score, the more anxiety a patient is experiencing.

    Time frame: 6-12 months

  5. Oxford Ankle Foot Questionnaire for Children

    Highest score possible is 100% and lowest score possible is 0%. The higher the score, the better functioning the ankle is.

    Time frame: 6-12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Individual participant data (IPD) will be shared following publication of the primary study results. Requests for data can be submitted 6 months after primary publication.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Apr 2032, 69 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2026
First posted
Aug 7, 2026
StartActual
Jun 8, 2026
Primary completionEst.
Apr 1, 2032
CompletionEst.
Apr 1, 2034
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
5 description edited
What changed in the outcomes
  • DescriptionHospital for Special Surgery Pediatric Functional Activity Bried Scale (HSS Pedi-FABS): how it is measured was reworded
  • DescriptionOxford Ankle Foot Questionnaire for Children: how it is measured was reworded
  • DescriptionPROMIS Anxiety: how it is measured was reworded
  • DescriptionPROMIS Mobility: how it is measured was reworded
  • DescriptionPROMIS Physical Activity: how it is measured was reworded
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Secondary outcomes 5 description edited
    What changed in the outcomes
    • DescriptionHospital for Special Surgery Pediatric Functional Activity Bried Scale (HSS Pedi-FABS): how it is measured was reworded
    • DescriptionOxford Ankle Foot Questionnaire for Children: how it is measured was reworded
    • DescriptionPROMIS Anxiety: how it is measured was reworded
    • DescriptionPROMIS Mobility: how it is measured was reworded
    • DescriptionPROMIS Physical Activity: how it is measured was reworded
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07751068
Lead sponsor
Texas Scottish Rite Hospital for Children
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Jun 8, 2026
Primary completion
Apr 1, 2032 (estimated)
Completion
Apr 1, 2034 (estimated)
Last update
Oct 30, 2026

Study contacts

Anna Wilhelmy, MS
Contact
anna.wilhelmy@tsrh.org
469-857-21109
Robert Van Pelt, MPH
Contact
bobby.vanpelt@tsrh.org
214-559-7456
Jacob Jones, MD
principal investigator · Scottish Rite for Children

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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