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NCT07803341
Clinical and Functional Outcomes After Subtalar Arthroereisis in Pediatric Flexible Flatfoot
Conditions: Pediatric Flexible Flatfoot
Sex: All
Ages: 10 Years – 18 Years
Healthy volunteers: Yes
Enrollment: 25
Sponsor: University of Pavia
Location: Istituto di Cura Città di Pavia Pavia Pavia
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.
Eligibility Criteria
Inclusion Criteria:
* Scheduled for elective subtalar arthroereisis, with or without adjunctive surgical procedures.
* Aged 10 to 18 years at the time of enrollment.
* Male or female.
Exclusion Criteria:
* Concomitant orthopedic or neurological conditions affecting walking ability.
* Neurological or vestibular disorders affecting balance.
* Contraindications to the medical devices used in the study.
* Inability to understand and sign the informed consent form.
Source: ClinicalTrials.gov (NCT07803341). StuddyBuddy aggregates publicly available trial information.