NCT06519175

Study of Infantile Lower Limb Malformations and Deformities

Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Deformity of Limb

Interventions

Type	Name	Description
OTHER	Conservative treatment	Patients are provided with physiotherapy support and the provision of prostheses with the goal of ensuring as much walking functionality as possible.
PROCEDURE	Single or multi-stage surgery	Correction of the deformity is pursued by one or more surgical procedures with the timing and the techniques (growth modulation, acute correction, gradual correction, soft tissues procedures, combined techniques) chosen according to the surgeon's preference to achieve the maximum possible walking functionality without orthopedic aids.
PROCEDURE	Amputation	Limb surgery, whether or not associated with realignment or soft-tissue surgery, is performed, aimed at providing the maximum possible walking function through a prosthesis.

Timeline

• Start date: 2024-10-31
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2024-07-25
• Last updated: 2025-12-26

Locations

7 sites across 1 country: Italy