Evaluation of a new implant for lower limb deformity in children
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up
This study looks at how well a new implant works for correcting lower limb deformities in children aged 8 to 15 who have had the procedure, by reviewing their medical records over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 8 Years to 15 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06525532 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 15 years who have undergone subtalar arthrorrhesis with the specified implant.
Not a fit: Patients with significant prior lower limb trauma, chronic infections, or other specified exclusions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of a new implant for treating lower limb deformities in children.
How similar studies have performed: While this approach is specific, similar studies evaluating pediatric orthopedic implants have shown promising results in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Massimiliano Mosca, MD
- Email: massimiliano.mosca@ior.it
- Phone: 0516366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.