Lower Limb Deformity
Conditions
Keywords
arthrorrhesis, reabsorbable endorthotic implant, subtalar joint, pediatric joint implant
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.
Interventions
OTHERfollow up
performing a 3 Tesla MRI of the operated foot
Sponsors
Istituto Ortopedico Rizzoli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactMassimiliano Mosca, MD
Backup ContactSilvio Caravelli, PhD
Outcome results
None listed