An observational study in Deformity of Limb, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 7 sites in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Istituto Ortopedico Rizzoli · Observational
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.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 250 across 257 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with congenital or acquired deformity of one or both lower limb diagnosed before skeletal maturity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Conservative treatment · Procedure: Single or multi-stage surgery · Procedure: Amputation
Patients are provided with physiotherapy support and the provision of prostheses with the goal of ensuring as much walking functionality as possible.
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.
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.
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)
Time frame: 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)
Time frame: After 1 year
Clinical examination with complete assessment of lower limbs
Full assessment of parameters about lower limb alignment
Time frame: At baseline (day 0)
Clinical examination with complete assessment of lower limbs
Full assessment of parameters about lower limb alignment
Time frame: After 1 year
Mental Health
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Time frame: At baseline (day 0)
Mental Health
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Time frame: After 1 year
Plan to share: Undecided
Started Oct 2024 (actual). Primary completion is estimated for May 2028, 43 months after the start.
Of 75 non-industry observational studies under Congenital Abnormalities, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 270. This study's planned 43 months is below that.
Counting every sponsor, half of 97 studies reached it within 49 months; a quarter within 23 and three quarters within 193.
How these figures are worked out, and which studies are left out of them.
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