RecruitingNCT06519175

Study of Infantile Lower Limb Malformations and Deformities

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

1,000 participants

Start Date

Oct 31, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

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

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Interventions

OTHERConservative treatment

Patients are provided with physiotherapy support and the provision of prostheses with the goal of ensuring as much walking functionality as possible.

PROCEDURESingle 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.

PROCEDUREAmputation

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.


Locations(7)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

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

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NCT06519175


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