Study of Infantile Lower Limb Malformations and Deformities

Condition(s) studied

Investigational drug(s) / intervention(s)

Conservative treatment: Patients 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: Correction 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: Limb surgery, whether or not associated with realignment or soft-tissue surgery, is performed, aimed at providing the maximum possible walking function through a prosthesis.

Study 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

Primary outcome measure(s)

• Pediatric Outcomes Data Collection Instrument — At baseline (day 0)
  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 — 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 — At baseline (day 0)
  Full assessment of parameters about lower limb alignment
• Clinical examination with complete assessment of lower limbs — After 1 year
  Full assessment of parameters about lower limb alignment
• Mental Health — At baseline (day 0)
  The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
• Mental Health — After 1 year
  The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

Trial sites (7)

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