Lateral Ankle Treatment

NCT07751068 | Recruiting DMC

• 1 other identifier: STU20251534
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Avulsion Fracture

Keywords

Avulsion Fracture; subfibular ossicle; Lateral ankle; short-leg cast

Outcome Measures

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.

  6-12 months

Secondary Outcomes (5)

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

  6-12 months

• PROMIS Physical Activity

  6-12 months

• PROMIS Mobility

  6-12 months

• PROMIS Anxiety

  6-12 months

• Oxford Ankle Foot Questionnaire for Children

  6-12 months

Study Arms (2)

Standard of Care Treatment

ACTIVE COMPARATOR

Procedure: Standard of Care (SOC)

Prolonged Immobilization (Casting)

EXPERIMENTAL

Procedure: Prolonged Immobilization (Casting)

Interventions

Prolonged Immobilization (Casting) PROCEDURE

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.

Prolonged Immobilization (Casting)

Standard of Care (SOC) PROCEDURE

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.

Standard of Care Treatment

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Previous ipsilateral ankle surgery
• Pre-existing musculoskeletal disease
• If patient has been casted prior to confirmation of avulsion fracture on imaging
• Developmental delay

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead

Study Sites (1)

Texas Scottish Rite Hospital for Children

Frisco, Texas, 75034, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 16801691 BACKGROUND

• 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.

  PMID: 17932408 BACKGROUND

• 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.

  PMID: 23965709 BACKGROUND

• 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.

  PMID: 24419825 BACKGROUND

• 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.

  PMID: 29992464 BACKGROUND

• 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.

  PMID: 1890128 BACKGROUND

MeSH Terms

Conditions

Fractures, Avulsion

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jacob Jones, MD

  Scottish Rite for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Wilhelmy, MS

CONTACT

469-857-21109; anna.wilhelmy@tsrh.org

Robert Van Pelt, MPH

CONTACT

214-559-7456; bobby.vanpelt@tsrh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: August 7, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2034
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)