Observing lower limb malformations in infants
Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities
This study looks at leg problems in kids under 18 to see how they affect health and family life, while also trying to create better treatment plans using new technology.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 7 sites (Bologna and 6 other locations) |
| Trial ID | NCT06519175 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on congenital and acquired deformities of the lower limbs in children under 18 years old. It aims to evaluate the impact of these conditions on physical and mental health, as well as family dynamics. The study seeks to develop a comprehensive assessment tool that can aid in personalized treatment plans, utilizing advancements in computer-assisted surgery and artificial intelligence. By involving patients and families in decision-making, the study hopes to improve outcomes and prevent complications.
Who should consider this trial
Good fit: Ideal candidates are children under 18 with congenital or acquired musculoskeletal deformities of one or both lower limbs.
Not a fit: Patients with mild deformities that do not cause functional limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better personalized treatment strategies for children with lower limb deformities.
How similar studies have performed: While similar studies have explored pediatric orthopedic deformities, this approach of integrating AI for personalized treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \< 18 years at the time of initial orthopedic evaluation * Diagnosis of congenital or acquired musculoskeletal deformity to one or both lower limbs * Presence of informed consent to participate in the study Exclusion Criteria: * Refuse to participate in the study by the patient or parent/legal guardian * Patients with mild paramorphisms not associated with functional limitations
Where this trial is running
Bologna and 6 other locations
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
- Istituto Giannina Gaslini — Genova, Italy (Not_yet_recruiting)
- Galeazzi Orthopedic Institute — Milan, Italy (Not_yet_recruiting)
- Policlinico San Matteo — Pavia, Italy (Not_yet_recruiting)
- Istituto Nazionale Tumori Regina Elena — Roma, Italy (Not_yet_recruiting)
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (Not_yet_recruiting)
- Istituto Clinico Humanitas — Rozzano, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Pierfrancesco Costici, MD — Ospedale Pediatrico Bambin Gesù
- Study coordinator: Giovanni Trisolino, MD
- Email: giovanni.trisolino@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.