Status:
RECRUITING
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Lower Limb Deformity
Eligibility:
All Genders
8-15 years
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06525532
Start Date
June 12 2024
End Date
December 1 2026
Last Update
December 29 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136