10-year follow-up after bilateral subtalar arthroereisis with calcaneal stop and endorthesis for correcting pediatric flatfoot
Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot
Istituto Ortopedico Rizzoli · NCT07569835
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT07569835 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Antonio Mazzotti Prof
- Email: antonio.mazzotti@ior.it
- Phone: +39 3498798863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Flat Foot Acquired Bilateral