Evaluation of a new implant for lower limb deformity in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will analyze cases of subtalar arthrorrhesis using a reabsorbable endorthotic implant made of PLLA, retrieved from the archives of the IRCCS Rizzoli Orthopedic Institute. An electronic database will be created to review the medical records of these patients, focusing on those aged 8 to 15 years who have undergone the procedure. The study will assess the outcomes over a minimum follow-up period of five years without a control group or comparison to other therapeutic procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Massimiliano Mosca, MD
• Email: massimiliano.mosca@ior.it
• Phone: 0516366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.