Study of Infantile Lower Limb Malformations and Deformities

Recruiting now

Conditions studied: Deformity of Limb

In brief

The skeletal defects of the lower limbs in pediatric age encompass various congenital and acquired conditions that alter bone structure. These alterations can be symmetrical or asymmetrical, with potential consequences such as deformities, short stature, and disability. These condictions may impact not only on the physical and the mental function of the children, but also on their family context. Management often requires a multidisciplinary approach for early diagnosis and treatment. Deformities are heterogeneous and necessitate a personalized therapeutic plan. Currently, in pediatric orthopedic surgery there is a lack of an instrument capable of evaluating all these aspects. The advancement of computer-assisted surgery and artificial intelligence could improve treatment customization and involve patients and families in therapeutic decision-making to prevent complications. This study aims to provide support for clinical practice to promote a systematic, comprehensive, and sequential evaluation of lower limb deformities in developmental age, from which epidemiological data and evidence on treatment approaches used in major referral centers can be extrapolated.

Key facts

Study ID

NCT06519175

Run by

Istituto Ortopedico Rizzoli

People needed

1000

Starts

2024-10-31

Expected to finish

2029-05-01

Last updated by the study team

2025-12-26

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Refuse to participate in the study by the patient or parent/legal guardian
• Patients with mild paramorphisms not associated with functional limitations

Where it is running

• IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (enrolling)
• Istituto Giannina Gaslini — Genova, Italy
• Galeazzi Orthopedic Institute — Milan, Italy
• Policlinico San Matteo — Pavia, Italy
• Istituto Nazionale Tumori Regina Elena — Roma, Italy
• Ospedale Pediatrico Bambino Gesù — Roma, Italy
• Istituto Clinico Humanitas — Rozzano, Italy

Full record on ClinicalTrials.gov

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