Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA (CS-RM)

Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up

From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed.

The eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).

The study will not present a control group or comparison groups between therapeutic procedures.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Deformity
• Intervention / Treatment: Other: follow up

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Massimiliano Mosca, MD; Phone Number: 0516366; Email: massimiliano.mosca@ior.it
• Study Contact Backup: Name: Silvio Caravelli, PhD; Phone Number: 0516366; Email: silvio.caravelli@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Massimiliano Mosca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

pediatric population with subtalar arthrorisis surgery with reabsorbable endorthesis implant in PLLA

Description

Inclusion Criteria:

• Age between 8 and 15 years at the time of surgery
• Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA
• Minimum follow-up of 5 years

Exclusion Criteria:

• Revisions/explantation of the endorthesis device
• Patients with active acute or chronic infections
• Patients with chronic inflammatory joint diseases
• Patients with previous significant trauma of the lower limbs following surgery
• Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias)
• Patients with cognitive deficits
• - Patients with concomitant neurological pathologies
• Patients suffering from tumor pathology
• Patients with cardiac pacemakers or other prostheses equipped with electronic circuits
• Patients with intracranial metal implants, metal heart valves, vascular clips, ferromagnetic endovascular filters/stents/coils, Swan-Ganz catheters or in any case positioned close to vital anatomical structures
• Patients with orthopedic metal prostheses
• Patients with cochlear implants or fixed hearing aids, lens prostheses with ferromagnetic intra-ocular points, IUD (coil) or splinters made of ferromagnetic material
• Pregnant patients
• Patients with insulin pumps and non-removable contact lenses

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; subjects who have undergone surgery for subtalar arthroritis with a reabsorbable endorthotic PLLA implant	Other: follow up; performing a 3 Tesla MRI of the operated foot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrumental evaluation	Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant	At baseline (Day 0)
evaluation of screw resorption	Clinical and Magnetic Resonance Imaging Results - PMC (nih.gov), Poly-L-lactic acid - hydroxyapatite (PLLA-HA) bioabsorbable interference screws for tibial graft fixation in anterior cruciate ligament (ACL) reconstruction surgery	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical evaluation - Ankle-Hindfoot score	AOFAS: this questionnaire consists of points assigned to nine items divided into three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) for a total of 100 points, the extreme of which represents a normal foot complex -ankle	at baseline (day 0)
Quality of life - SF-12	The SF-12 health questionnaire is a standardized generic instrument for the rapid, economical and disease-free acquisition of the patient's health-related quality of life.	at baseline

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Benedetti MG, Ceccarelli F, Berti L, Luciani D, Catani F, Boschi M, Giannini S. Diagnosis of flexible flatfoot in children: a systematic clinical approach. Orthopedics. 2011 Jan 1;34(2):94. doi: 10.3928/01477447-20101221-04.
• Kim MK, Lee YS. Kinematic analysis of the lower extremities of subjects with flat feet at different gait speeds. J Phys Ther Sci. 2013 May;25(5):531-3. doi: 10.1589/jpts.25.531. Epub 2013 Jun 29.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: subtalar joint; arthrorrhesis; reabsorbable endorthotic implant; pediatric joint implant
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CS-RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No