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Clinical Trials in Italy / NCT06525532
Recruiting Observational

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

NCT06525532 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Observational
Started
2024-06-12
Last updated
2025-12-29

Condition(s) studied

Lower Limb Deformity

Investigational drug(s) / intervention(s)

follow up

follow up: performing a 3 Tesla MRI of the operated foot

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
15 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06525532 on ClinicalTrials.gov ↗ ← All trials in Italy