Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA

Recruiting

• Conditions: Lower Limb Deformity
• Interventions: Other: follow up

• Registration Number: NCT06525532
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	follow up	subjects who have undergone surgery for subtalar arthroritis with a reabsorbable endorthotic PLLA implant

Primary Outcome Measures

Name	Time	Method
Instrumental evaluation	At baseline (Day 0)	Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant
evaluation of screw resorption	at baseline	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

Secondary Outcome Measures

Name	Time	Method
clinical evaluation - Ankle-Hindfoot score	at baseline (day 0)	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
Quality of life - SF-12	at baseline	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy