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

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.

Study Overview

• Status: Recruiting
• Conditions: Flat Foot Acquired Bilateral (Pes Planus)
• Intervention / Treatment: Other: calcaneo stop and endorthesis

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Antonio Mazzotti Prof; Phone Number: +39 3498798863; Email: antonio.mazzotti@ior.it

Study Locations

• Italy
  • Bologna, Italy
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Antonio Mazzotti Prof; Phone Number: +39 3498798863; Email: antonio.mazzotti@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Primary objective:

To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot.

Secondary objectives:

To compare, within the same patient, the clinical and radiological outcomes of feet treated with subtalar arthroereisis using calcaneostop versus endorthosis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients who underwent subtalar arthroereisis with calcaneostop and endorthosis	Other: calcaneo stop and endorthesis; To evaluate, at more than ten years' follow-up, the clinical and radiological outcomes of patients who underwent subtalar arthroereisis with calcaneostop and endorthosis for the correction of pediatric flatfoot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS (Visual Analog Scale)	A scale used to measure the subjective characteristics of pain experienced by the patient, ranging from 0 (no pain) to 10 (worst imaginable pain).	may 2024 may 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEARY'S ANGLE	Measured between the axis of the talus and that of the first metatarsal on a weight-bearing lateral foot radiograph	may 2024 may 2027
TALO-CALCANEAL ANGLE	Measured between the axis of the talus and that of the calcaneus on a weight-bearing dorsoplantar foot radiograph.	may 2024 may 2027
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 tiptoe.	may2024 - may 2027
jACK TEST	this consists of passive extension of the big toe under weight-bearing. If the previously absent arch reappears, the flatfoot is flexible.	may 2024 - may 2027
TIPTOE WALKING	The patient walks for about ten steps on tiptoe, and the examiner observes any varus alignment of the hindfoot and the reformation of the plantar arch.	may 2024 - may 2027
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	may 2024 - may 2027

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): April 21, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Talipes; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Flatfoot
• Other Study ID Numbers: ARTRO-LONG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No