Study of Infantile Lower Limb Malformations and Deformities
NCT Number: NCT06519175
Acronym: REMEDIA-I
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Deformity of Limb
Interventions: OTHER: Conservative treatment|PROCEDURE: Single or multi-stage surgery|PROCEDURE: Amputation
Sponsor: Istituto Ortopedico Rizzoli
Collaborators: Ospedale Pediatrico Bambino Gesù|Istituto Giannina Gaslini|Galeazzi Orthopedic Institute|Istituto Nazionale Tumori Regina Elena|Policlinico San Matteo|Istituto Clinico Humanitas
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2029-05
Locations: IRCCS Istituto Ortopedico Rizzoli, Bologna, 40136, Italy|Istituto Giannina Gaslini, Genova, Italy|Galeazzi Orthopedic Institute, Milano, Italy|Policlinico San Matteo, Pavia, Italy|Istituto Nazionale Tumori Regina Elena, Roma, Italy|Ospedale Pediatrico Bambino Gesù, Roma, Italy|Istituto Clinico Humanitas, Rozzano, Italy

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.

Primary Outcome Measures: 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), At baseline (day 0)|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), After 1 year|Clinical examination with complete assessment of lower limbs, Full assessment of parameters about lower limb alignment, At baseline (day 0)|Clinical examination with complete assessment of lower limbs, Full assessment of parameters about lower limb alignment, After 1 year|Mental Health, The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health., At baseline (day 0)|Mental Health, The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health., After 1 year