Study of Infantile Lower Limb Malformations and Deformities

Recruiting

• Conditions: Deformity of Limb
• Interventions: Other: Conservative treatment; Procedure: Single or multi-stage surgery; Procedure: Amputation

• Registration Number: NCT06519175
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2028-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children and adolescent with lower limb deformities	Amputation	-
Children and adolescent with lower limb deformities	Conservative treatment	-
Children and adolescent with lower limb deformities	Single or multi-stage surgery	-

Primary Outcome Measures

Name	Time	Method
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	After 1 year	Full assessment of parameters about lower limb alignment
Mental Health	After 1 year	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

Trial Locations

Locations (7)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy

Istituto Giannina Gaslini; 🇮🇹 Genova, Italy

Galeazzi Orthopedic Institute; 🇮🇹 Milano, Italy

Policlinico San Matteo; 🇮🇹 Pavia, Italy

Istituto Nazionale Tumori Regina Elena; 🇮🇹 Roma, Italy

Ospedale Pediatrico Bambino Gesù; 🇮🇹 Roma, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy