Study of Infantile Lower Limb Malformations and Deformities

Official title

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

Overview

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.

Interventions

• Other Conservative treatment
  Patients are provided with physiotherapy support and the provision of prostheses with the goal of ensuring as much walking functionality as possible.
• Procedure 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.
• 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.

Primary outcome measures

• Pediatric Outcomes Data Collection Instrument [Time frame: At baseline (day 0)]
• Pediatric Outcomes Data Collection Instrument [Time frame: After 1 year]
• Clinical examination with complete assessment of lower limbs [Time frame: At baseline (day 0)]
• Clinical examination with complete assessment of lower limbs [Time frame: After 1 year]
• Mental Health [Time frame: At baseline (day 0)]
• Mental Health [Time frame: After 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 7 centers

• IRCCS Istituto Ortopedico Rizzoli — Bologna
• Istituto Giannina Gaslini — Genova
• Galeazzi Orthopedic Institute — Milan
• Policlinico San Matteo — Pavia
• Istituto Nazionale Tumori Regina Elena — Roma
• Ospedale Pediatrico Bambino Gesù — Roma
• Istituto Clinico Humanitas — Rozzano

Publications

• Herring J, Tachdjian's Pediatric Orthopaedics: From the Texas Scottish Rite Hospital for Children, 6th edition. Elsevier, 2020.
• Sabharwal S. Pediatric Lower Limb Deformities: Principles and Techniques of Management. Springer 2015.
• Gupta P, Gupta V, Patil B, Verma V. Angular deformities of lower limb in children: Correction for whom, when and how? J Clin Orthop Trauma. 2020 Mar-Apr;11(2):196-201. doi: 10.1016/j.jcot.2020.01.008. Epub 2020 Jan 27. PMID 32099279
• Chhina H, Klassen AF, Kopec JA, Oliffe J, Iobst C, Dahan-Oliel N, Aggarwal A, Nunn T, Cooper AP. What matters to children with lower limb deformities: an international qualitative study guiding the development of a new patient-reported outcome measure. J Patient Rep Outcomes. 2021 Apr 1;5(1):30. doi: 10.1186/s41687-021-00299-w. PMID 33792793
• Iobst C. Limb lengthening combined with deformity correction in children with the Taylor Spatial Frame. J Pediatr Orthop B. 2010 Nov;19(6):529-34. doi: 10.1097/BPB.0b013e32833dec43. PMID 20739904
• Frizziero L, Santi GM, Liverani A, Napolitano F, Papaleo P, Maredi E, Gennaro GLD, Zarantonello P, Stallone S, Stilli S, et al. Computer-Aided Surgical Simulation for Correcting Complex Limb Deformities in Children. Applied Sciences. 2020; 10(15):5181.
• Blobel B, Ruotsalainen P, Oemig F, Giacomini M, Sottile PA, Endsleff F. Principles and Standards for Designing and Managing Integrable and Interoperable Transformed Health Ecosystems. J Pers Med. 2023 Nov 4;13(11):1579. doi: 10.3390/jpm13111579. PMID 38003894
• Stuberg W, Temme J, Kaplan P, Clarke A, Fuchs R. Measurement of tibial torsion and thigh-foot angle using goniometry and computed tomography. Clin Orthop Relat Res. 1991 Nov;(272):208-12. PMID 1934735

Identifiers

NCT: NCT06519175 · REMEDIA-I

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗