Study of Infantile Lower Limb Malformations and Deformities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2029-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Deformity of Limb

Keywords

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Pediatric orthopedics Deformity Patient Reported Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Children and adolescent with lower limb deformities

Conservative treatment

Intervention Type OTHER

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Interventions

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Conservative treatment

Patients are provided with physiotherapy support and the provision of prostheses with the goal of ensuring as much walking functionality as possible.

Intervention Type OTHER

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierfrancesco Costici, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Pediatrico Bambin Gesù

Giorgio Marrè Brunenghi, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Giannina Gaslini

Fabio Verdoni, MD

Role: PRINCIPAL_INVESTIGATOR

Galeazzi Orthopedic Institute

Roberto Biagini, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Nazionale Tumori Regina Elena

Gianluigi Pasta, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico San Matteo

Tommaso Bonanzinga, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING