10-year follow-up after bilateral subtalar arthroereisis with calcaneal stop and endorthesis for correcting pediatric flatfoot
Official title: Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot
Run by Istituto Ortopedico Rizzoli · NCT07569835 · Data updated 2026-11-12
This follow-up will see if children and adolescents who had bilateral subtalar arthroereisis with calcaneal stop and endorthesis keep their flatfoot correction and remain free of pain over 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | May 30, 2024 |
| Main results expected | April 21, 2026 |
| Study ends | May 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT07569835 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients already in follow-up at Istituto Ortopedico Rizzoli who previously underwent subtalar arthroereisis with calcaneal stop and endorthesis for bilateral flatfoot.
✕Probably not a fit
Patients who have had subsequent foot or ankle surgery or who are no longer followed at the Rizzoli center are not eligible and would not benefit from this follow-up protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center observational follow-up of patients previously treated with bilateral subtalar arthroereisis using a calcaneal stop and an endorthesis and currently in follow-up at Istituto Ortopedico Rizzoli. Clinical measures will include the tip-toe test, Jack test, and tip-toe walking test, while radiographic evaluation will measure Meary's angle and the talocalcaneal angle on lateral foot views. Secondary outcomes include patient-reported pain using the VAS and footprint analysis with a podoscope. Patients who underwent additional foot or ankle surgery after the index procedure are excluded.
Why it matters
Potential benefit: If successful, the follow-up could confirm long-term durability of the surgical correction and low pain rates, helping patients and clinicians decide on this treatment approach.
How similar studies have gone: Previous studies of subtalar arthroereisis show generally favorable short- to mid-term outcomes, but long-term data specifically on the combined calcaneal stop and endorthesis approach remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: Patients already in follow-up after undergoing subtalar arthroereisis with calcaneostop and endorthosis, enrolled in the study "Flatfoot treatment: comparison between resorbable endorthosis and resorbable calcaneal stop" by Prof. Giannini, still in follow-up at IOR. EXCLUSION CRITERIA: Patients who have undergone subsequent surgical procedures on the foot and ankle
Where it's running
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Istituto Ortopedico Rizzoli
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Antonio Mazzotti Prof
- Email: antonio.mazzotti@ior.it
- Phone: +39 3498798863
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.