Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA
NCT ID: NCT06525532
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
35 participants
OBSERVATIONAL
2024-06-12
2026-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
subjects who have undergone surgery for subtalar arthroritis with a reabsorbable endorthotic PLLA implant
follow up
performing a 3 Tesla MRI of the operated foot
Interventions
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follow up
performing a 3 Tesla MRI of the operated foot
Eligibility Criteria
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Inclusion Criteria
* Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA
* Minimum follow-up of 5 years
Exclusion Criteria
* 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
8 Years
15 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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Massimiliano Mosca, MD
Role: primary
References
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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.
Other Identifiers
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CS-RM
Identifier Type: -
Identifier Source: org_study_id