About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refuse to participate in the study by the patient or parent/legal guardian
Patients with mild paramorphisms not associated with functional limitations
Trial population
Patients with congenital or acquired deformity of one or both lower limb diagnosed before skeletal maturity.
Trial design
Cohort
Other
Treatments tested in this trial
Conservative treatment
Other interventionPatients are provided with physiotherapy support and the provision of prostheses with the goal of ensuring as much walking functionality as possible.
Single or multi-stage surgery
Procedure/SurgeryCorrection 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.
Amputation
Procedure/SurgeryLimb surgery, whether or not associated with realignment or soft-tissue surgery, is performed, aimed at providing the maximum possible walking function through a prosthesis.
Treatment groups
Trial outcomes
Primary outcomes
Pediatric Outcomes Data Collection Instrument
The scores, reported by the child and the caregiver, on the items of the questionnaire, which includes upper extremity (UE), transfer/basic mobility (TBM), happiness (Hap), sports/physical function (SPF), pain/comfort (PC)
Pediatric Outcomes Data Collection Instrument
The scores, reported by the child and the caregiver, on the items of the questionnaire, which includes upper extremity (UE), transfer/basic mobility (TBM), happiness (Hap), sports/physical function (SPF), pain/comfort (PC)
Clinical examination with complete assessment of lower limbs
Full assessment of parameters about lower limb alignment
Clinical examination with complete assessment of lower limbs
Full assessment of parameters about lower limb alignment
Sponsors and contacts
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Istituto Ortopedico Rizzoli
Lead sponsor
Ospedale Pediatrico Bambino Gesù
Collaborator
Istituto Giannina Gaslini
Collaborator
Galeazzi Orthopedic Institute
Collaborator
Istituto Nazionale Tumori Regina Elena
Collaborator
Policlinico San Matteo
Collaborator
Istituto Clinico Humanitas
Collaborator