Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Deformity of Limb
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 1000
- Locations
- 7
- Primary Endpoint
- Pediatric Outcomes Data Collection Instrument
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Pediatric Outcomes Data Collection Instrument
Time Frame: After 1 year
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
Time Frame: After 1 year
Full assessment of parameters about lower limb alignment
Mental Health
Time Frame: After 1 year
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.