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NCT Number: NCT06519175

Study of Infantile Lower Limb Malformations and Deformities

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.

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Key information

Conditions

Deformity of Limb Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pediatric Outcomes Data Collection Instrument

    Time frame: At baseline (day 0)

    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)

  2. Pediatric Outcomes Data Collection Instrument

    Time frame: 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)

  3. Clinical examination with complete assessment of lower limbs

    Time frame: At baseline (day 0)

    Full assessment of parameters about lower limb alignment

  4. Clinical examination with complete assessment of lower limbs

    Time frame: After 1 year

    Full assessment of parameters about lower limb alignment

  5. Mental Health

    Time frame: At baseline (day 0)

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

  6. Mental Health

    Time frame: After 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Depaoli, MD

CONTACT

[email protected]

Giovanni Trisolino, MD

CONTACT

[email protected]

0516366 ext. 484

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Galeazzi Orthopedic Institute
  • Istituto Clinico Humanitas
  • Istituto Giannina Gaslini
  • Istituto Nazionale Tumori Regina Elena
  • Ospedale Pediatrico Bambino Gesù
  • Policlinico San Matteo

Registry information

Official study title

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

Acronym: REMEDIA-I

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jul 25, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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