Actively Recruiting

All Genders
NCT07569835

Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot

Led by Istituto Ortopedico Rizzoli · Updated on 2026-05-06

20

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

VARIABLES TO BE COLLECTED AND SOURCE The primary efficacy endpoint will be the maintenance of flatfoot correction over time, assessed both clinically (tip-toe test, Jack test, tip-toe walking test) and radiologically (evaluation of Meary's angle on the lateral foot view and the talocalcaneal angle). The secondary efficacy endpoint will be the absence of pain at follow-up, assessed using the VAS scale, and evaluation of the footprint using a podoscope. TIP-TOE TEST: The patient is observed under weight-bearing conditions and then while rising onto the toes. If the foot is flexible, the plantar arch-previously absent-reappears when standing on tip-toe. JACK TEST: This consists of passive dorsiflexion of the hallux under weight-bearing conditions. If the previously absent arch reappears, the flatfoot is considered flexible. TIP-TOE WALKING TEST: The patient walks for about ten steps on tip-toe. The examiner observes any varus alignment of the hindfoot and reconstruction of the plantar arch. MEARY'S ANGLE: Measured between the longitudinal axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph. TALOCALCANEAL ANGLE: Measured between the longitudinal axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph. VAS: The Visual Analog Scale for pain is a tool used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain). PODOSCOPE FOOTPRINT ASSESSMENT: Evaluation of the isthmus (the narrow portion of the footprint connecting the heel to the forefoot). The foot is considered normal when the width of the isthmus is between one-third and one-half of the maximum width of the forefoot. SAMPLE SIZE AND STATISTICS In Prof. Giannini's study, 30 patients were enrolled; approximately 30% were lost to follow-up over 12 years. Barring further losses, about 20 patients currently followed at Clinic I are expected to be available. ENROLLMENT PROCEDURE Eligible patients will be enrolled in the study only after providing written informed consent. No data collection, procedures, or analyses will be performed prior to obtaining consent. DATA COLLECTION Clinical data required for the study will be extracted from patients' medical records and source documents. A dedicated data collection form will be used to record clinical information and the results of the analyses by the study. For each enrolled patient, a Case Report Form (CRF) will be completed.

CONDITIONS

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients already in follow-up after undergoing subtalar arthroereisis with calcaneostop and endorthesis
  • Enrolled in the study "Flatfoot treatment: comparison between resorbable endorthosis and resorbable calcaneal stop" by Prof. Giannini
  • Still in follow-up at IOR
Not Eligible

You will not qualify if you...

  • Patients who have undergone subsequent surgical procedures on the foot and ankle

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy

Actively Recruiting

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Research Team

A

Antonio Mazzotti Prof

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Clinical and Radiological Evaluation Over 10 Years After Bilateral Subtalar Arthrorisis Surgery With Endorthesis and Calcaneal Stop for the Correction of Pediatric Flatfoot | DecenTrialz