Observing lower limb malformations in infants
Official title: Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities
Run by Istituto Ortopedico Rizzoli · NCT06519175 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 7 sites (Bologna and 6 other locations) |
| Status | Recruiting |
| Started | October 31, 2024 |
| Main results expected | May 2028 |
| Study ends | May 2029 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT06519175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children under 18 with congenital or acquired musculoskeletal deformities of one or both lower limbs.
✕Probably not a fit
Patients with mild deformities that do not cause functional limitations may not benefit from this study.
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 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.
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 gone: While similar studies have explored pediatric orthopedic deformities, this approach of integrating AI for personalized treatment is relatively novel.
Who can join: the full rules
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 it's running
-
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
Show 1 more location
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating the safety and effectiveness of pediatric orthopedic implants
This study is testing how safe and effective orthopedic implants are for kids with fractures and limb deformities to see how they perform over time.
-
Growth-plate behavior during and after temporary hemi‑epiphysiodesis and epiphysiodesis using RSA
This project will use radiostereometric analysis (RSA) with tiny implanted markers to test whether surgeons can precisely track growth of the growth plate in children treated for limb‑length differences or angular deformities.
-
Archive of Custom-Made Guides for Orthopedic Surgery
Researchers are testing a digital archive to store and track patient-specific cutting guides used in orthopedic surgeries for people with bone deformities.
-
Use of reconstructive microsurgery to treat lymphedema
This study tests whether reconstructive microsurgery, with or without the help of indocyanine green imaging, can help people with lymphedema feel and function better by improving lymphatic drainage.
-
ACL reconstruction using the Over-The-Top technique with either metal staples or soft anchors
This study tests whether using a suture-based fixation (soft anchors) during OTT ACL reconstruction works as well as metal staples for graft stability in adults aged 18–50.
-
Biomarkers in circulating vesicles for Ewing sarcoma
Researchers will test blood samples from people with Ewing sarcoma to see if circulating biomarkers in extracellular vesicles can help validate new therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.