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Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot

NCT07803341 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2026-09-03

No results posted yet for this study

Summary

Flexible flatfoot is common in children and adolescents. In some patients, the condition remains painful or limits activity despite non-surgical treatment. Subtalar arthroereisis is a minimally invasive operation in which an implant is placed in the sinus tarsi to limit excessive foot pronation while preserving joint movement.

This observational study follows children and adolescents who receive subtalar arthroereisis as part of their planned clinical care. Clinical status, standing foot radiographs, plantar-pressure distribution, and walking characteristics are assessed before surgery and six months after surgery. The study aims primarily to describe changes in dynamic plantar loading and walking parameters. Changes in clinical scores and radiographic alignment are assessed as secondary outcomes. No treatment is assigned for research purposes, and all surgical and postoperative decisions are made according to routine clinical indications.

Conditions

  • Pediatric Flexible Flatfoot

Interventions

PROCEDURE

Subtalar Arthroereisis

A conical titanium implant is inserted into the sinus tarsi through a minimally invasive approach to restrict excessive subtalar pronation while preserving joint mobility. Implant size and position are assessed clinically and under fluoroscopic guidance. Additional soft-tissue or navicular procedures may be performed when clinically indicated, including gastrocnemius lengthening; excision or regularization of a symptomatic accessory or prominent navicular; posterior tibial tendon reinsertion or retensioning; or anterior tibial tendon tenosuspension according to the Young technique. These procedures are determined by clinical need and are not assigned by the study protocol.

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803341 on ClinicalTrials.gov