Study of Infantile Lower Limb Malformations and Deformities

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorIstituto Ortopedico Rizzoli

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Conservative treatment

    Other intervention

    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

    Procedure/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

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Children and adolescent with lower limb deformities3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
At baseline (day 0)
2

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)

Time frame
After 1 year
3

Clinical examination with complete assessment of lower limbs

Full assessment of parameters about lower limb alignment

Time frame
At baseline (day 0)
4

Clinical examination with complete assessment of lower limbs

Full assessment of parameters about lower limb alignment

Time frame
After 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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