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Clinical Trials/NCT06519175
NCT06519175
Recruiting
Not Applicable

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

Istituto Ortopedico Rizzoli7 sites in 1 country1,000 target enrollmentOctober 31, 2024

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2024
End Date
May 1, 2029
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Study Sites (7)

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