Study of Infantile Lower Limb Malformations and Deformities

NCT06519175 | Recruiting

• 1 other identifier: REMEDIA-I
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Deformity of Limb

Keywords

Pediatric orthopedics; Deformity; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (6)

• 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)

  At baseline (day 0)

• 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)

  After 1 year

• Clinical examination with complete assessment of lower limbs

  Full assessment of parameters about lower limb alignment

  At baseline (day 0)

• Clinical examination with complete assessment of lower limbs

  Full assessment of parameters about lower limb alignment

  After 1 year

• Mental Health

  The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

  At baseline (day 0)

• Mental Health

  The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

  After 1 year

Study Arms (1)

Children and adolescent with lower limb deformities

Other: Conservative treatment; Procedure: Single or multi-stage surgery; Procedure: Amputation

Interventions

Conservative treatment OTHER

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

Children and adolescent with lower limb deformities

Single or multi-stage surgery 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.

Children and adolescent with lower limb deformities

Amputation 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.

Children and adolescent with lower limb deformities

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital or acquired deformity of one or both lower limb diagnosed before skeletal maturity.

You may qualify if:

• 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

You may not qualify if:

• Refuse to participate in the study by the patient or parent/legal guardian
• Patients with mild paramorphisms not associated with functional limitations

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• 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

Study Sites (7)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Istituto Giannina Gaslini

Genova, Italy

NOT YET RECRUITING

Galeazzi Orthopedic Institute

Milan, Italy

NOT YET RECRUITING

Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

Istituto Nazionale Tumori Regina Elena

Roma, Italy

NOT YET RECRUITING

Ospedale Pediatrico Bambino Gesù

Roma, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas

Rozzano, Italy

NOT YET RECRUITING

Related Publications (11)

• Herring J, Tachdjian's Pediatric Orthopaedics: From the Texas Scottish Rite Hospital for Children, 6th edition. Elsevier, 2020.

  BACKGROUND

• Sabharwal S. Pediatric Lower Limb Deformities: Principles and Techniques of Management. Springer 2015.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Beighton P, Horan F. Orthopaedic aspects of the Ehlers-Danlos syndrome. J Bone Joint Surg Br. 1969 Aug;51(3):444-53. No abstract available.

  PMID: 5820785 BACKGROUND

• Dodwell ER, Pathy R, Widmann RF, Green DW, Scher DM, Blanco JS, Doyle SM, Daluiski A, Sink EL. Reliability of the Modified Clavien-Dindo-Sink Complication Classification System in Pediatric Orthopaedic Surgery. JB JS Open Access. 2018 Oct 23;3(4):e0020. doi: 10.2106/JBJS.OA.18.00020. eCollection 2018 Dec 20.

  PMID: 30882054 BACKGROUND

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Conservative Treatment; Single Person; Amputation, Surgical

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Pierfrancesco Costici, MD

  Ospedale Pediatrico Bambin Gesù

  PRINCIPAL INVESTIGATOR

• Giorgio Marrè Brunenghi, MD

  Istituto Giannina Gaslini

  PRINCIPAL INVESTIGATOR

• Fabio Verdoni, MD

  Galeazzi Orthopedic Institute

  PRINCIPAL INVESTIGATOR

• Roberto Biagini, MD

  Istituto Nazionale Tumori Regina Elena

  PRINCIPAL INVESTIGATOR

• Gianluigi Pasta, MD

  Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

• Tommaso Bonanzinga, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Trisolino, MD

CONTACT

0516366; giovanni.trisolino@ior.it

Alessandro Depaoli, MD

CONTACT

alessandro.depaoli@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: July 25, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

IT (7)