Clinical trial NCT06519175: Study of Infantile Lower Limb Malformations and Deformities
Official title: Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deformity of Limb
Keywords: Pediatric orthopedics
Deformity
Patient Reported Outcomes
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Ospedale Pediatrico Bambino Gesù
name: Istituto Giannina Gaslini
name: Galeazzi Orthopedic Institute
name: Istituto Nazionale Tumori Regina Elena
name: Policlinico San Matteo
name: Istituto Clinico Humanitas
First posted: 2024-07-25
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congenital or acquired deformity of one or both lower limb diagnosed before skeletal maturity.

Brief 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 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

Primary outcomes:
measure: Pediatric Outcomes Data Collection Instrument
timeFrame: At baseline (day 0)
measure: Pediatric Outcomes Data Collection Instrument
timeFrame: After 1 year
measure: Clinical examination with complete assessment of lower limbs
timeFrame: At baseline (day 0)
measure: Clinical examination with complete assessment of lower limbs
timeFrame: After 1 year
measure: Mental Health
timeFrame: At baseline (day 0)
measure: Mental Health
timeFrame: After 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Galeazzi Orthopedic Institute
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
Study officials:
affiliation: Ospedale Pediatrico Bambin Gesù
name: Pierfrancesco Costici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Giannina Gaslini
name: Giorgio Marrè Brunenghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Galeazzi Orthopedic Institute
name: Fabio Verdoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Nazionale Tumori Regina Elena
name: Roberto Biagini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico San Matteo
name: Gianluigi Pasta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Clinico Humanitas
name: Tommaso Bonanzinga, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Sabharwal S. Pediatric Lower Limb Deformities: Principles and Techniques of Management. Springer 2015.
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