Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: follow up.
- Who it may be relevant to
- Registry conditions: Lower Limb Deformity. Basic parameters: 8 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up
Overview
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.
Interventions
- Other follow up
performing a 3 Tesla MRI of the operated foot
Primary outcome measures
- Instrumental evaluation [Time frame: At baseline (Day 0)]
- evaluation of screw resorption [Time frame: at baseline]
Secondary outcome measures (2)
- clinical evaluation - Ankle-Hindfoot score [Time frame: at baseline (day 0)]
- Quality of life - SF-12 [Time frame: at baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
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. PMID 21323297
- 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. PMID 24259795
Identifiers
NCT: NCT06525532 · CS-RM