Study of Infantile Lower Limb Malformations and Deformities (REMEDIA-I)

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Deformity of Limb

Treatments

Procedure: Amputation

Procedure: Single or multi-stage surgery

Other: Conservative treatment

Study type

Observational

Funder types

Other

Identifiers

NCT06519175

REMEDIA-I

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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