Surgical treatment for flexible flatfoot in children
Official title: Prospective Evaluation of Patients Undergoing Surgical Treatment for Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for the Treatment of Flexible Flatfoot in the Growth Age
Run by Istituto Ortopedico Rizzoli · NCT06091371 · Data updated 2026-11-12
This study is testing a surgery to see if it can help children aged 8 to 14 with flexible flatfoot by improving the alignment of their foot bones as they grow.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years to 14 Years |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | August 2, 2024 |
| Trial ID | NCT06091371 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 8 to 14 with idiopathic, flexible, symptomatic flatfoot.
✕Probably not a fit
Patients with joint laxity, neuromuscular disorders, neurological conditions, traumatic sequelae, iatrogenic flatfoot, or congenital flatfoot due to tarsal synostosis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the outcomes of a surgical procedure called arthrorisis of the subtalar joint using a polymeric endorthesis to treat flexible flatfoot in children aged 8 to 14. The goal is to restore proper joint alignment between the astragalus and calcaneus, allowing for natural bone remodeling as the child grows. The study will prospectively analyze clinical and radiographic data over time in a series of 55 patients to assess the effectiveness of this intervention.
Why it matters
Potential benefit: If successful, this approach could provide a long-term solution for children suffering from flexible flatfoot, improving their mobility and quality of life.
How similar studies have gone: While there are various surgical interventions for flatfoot, this specific approach using a polymeric endorthesis has not been extensively studied in a prospective manner, making it a novel evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Idiopathic, flexible, symptomatic flatfoot * Patients aged between 8 and 14 years Exclusion Criteria: * Joint laxity * Neuromuscular disorders * Neurological conditions * Traumatic sequelae * Iatrogenic flatfoot * Congenital flatfoot due to tarsal synostosis
Where it's running
-
Istituto Ortopedico Rizzoli
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Antonio Mazzotti, MD PhD
- Email: antonio.mazzotti@ior.it
- Phone: 0516445064
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.