Deformity of LimbREMEDIA-INCT06519175
Study of Infantile Lower Limb Malformations and Deformities
An observational study of Deformity of Limb, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Deformity of Limb
- What is being tested?
- Conservative treatment, Single or multi-stage surgery and Amputation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 7 sitesItaly
- Study dates
- 31 Oct 2024to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with congenital or acquired deformity of one or both lower limb diagnosed before skeletal maturity.
Who may be able to join
- 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
Who cannot join
- Refuse to participate in the study by the patient or parent/legal guardian
- Patients with mild paramorphisms not associated with functional limitations
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alessandro Depaoli, MD contact
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Giovanni Trisolino, MD, 05163666 ext. 484, giovanni.trisolino@ior.it
- Not yet recruiting
Istituto Giannina Gaslini
Genova
Giorgio Marrè Brunenghi, MD, giorgiomarre@gaslini.org
- Not yet recruiting
Galeazzi Orthopedic Institute
Milan
Fabio Verdoni, MD, fabio.verdoni@grupposandonato.it
- Not yet recruiting
Policlinico San Matteo
Pavia
Gianluigi Pasta, MD
- Not yet recruiting
Istituto Nazionale Tumori Regina Elena
Roma
Roberto Biagini, MD, roberto.biagini@ifo.it
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma
Pier Francesco Costici, MD, pierfrancesco.costici@opbg.net
- Not yet recruiting
Istituto Clinico Humanitas
Rozzano
Tommaso Bonanzinga, MD, tommaso.bonanzinga@hunimed.eu
About this study
Official title: Observational Retrospective and Prospective 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.
Read more
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
- Being tested
- Conservative treatment, Single or multi-stage surgery, Amputation
- Keywords
- Pediatric orthopedics, Deformity, Patient Reported Outcomes
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentOther
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 surgeryProcedure or 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.
AmputationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescent with lower limb deformities | Not described Receives: Other: Conservative treatment; Procedure: Single or multi-stage surgery; Procedure: Amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: After 1 year
Clinical examination with complete assessment of lower limbs
Full assessment of parameters about lower limb alignment
Measured: At baseline (day 0)
Clinical examination with complete assessment of lower limbs
Full assessment of parameters about lower limb alignment
Measured: After 1 year
Mental Health
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Measured: At baseline (day 0)
Mental Health
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start31 Oct 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Deformity of LimbStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Pediatrico Bambino Gesù, Istituto Giannina Gaslini, Galeazzi Orthopedic Institute, Istituto Nazionale Tumori Regina Elena, Policlinico San Matteo, Istituto Clinico Humanitas
- Responsible party
- Sponsor
- Investigators
- Pierfrancesco Costici, MD, Principal investigator, Ospedale Pediatrico Bambin GesùGiorgio Marrè Brunenghi, MD, Principal investigator, Istituto Giannina GasliniFabio Verdoni, MD, Principal investigator, Galeazzi Orthopedic InstituteRoberto Biagini, MD, Principal investigator, Istituto Nazionale Tumori Regina ElenaGianluigi Pasta, MD, Principal investigator, Policlinico San MatteoTommaso Bonanzinga, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519175
- Sponsor's protocol ID
- REMEDIA-I
- Acronym
- REMEDIA-I
- Status last verified
- Dec 2025
- First submitted
- 6 May 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32099279Chhina 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.
PubMed 33792793Iobst 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.
PubMed 20739904Frizziero 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.
PubMed 38003894Stuberg 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.
PubMed 1934735Beighton P, Horan F. Orthopaedic aspects of the Ehlers-Danlos syndrome. J Bone Joint Surg Br. 1969 Aug;51(3):444-53. No abstract available.
PubMed 5820785Dodwell 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.
PubMed 30882054Harris 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.
PubMed 31078660
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities
- ClinicalTrials.gov ID
- NCT06519175
- Acronym / sponsor ID
- REMEDIA-I / REMEDIA-I
- Conditions
- Deformity of Limb
- Keywords
- Pediatric orthopedics, Deformity, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Ospedale Pediatrico Bambino Gesù, Istituto Giannina Gaslini, Galeazzi Orthopedic Institute, Istituto Nazionale Tumori Regina Elena, Policlinico San Matteo, Istituto Clinico Humanitas
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescent with lower limb deformities | – | Other: Conservative treatment, Procedure: Single or multi-stage surgery, Procedure: Amputation |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with congenital or acquired deformity of one or both lower limb diagnosed before skeletal maturity.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Refuse to participate in the study by the patient or parent/legal guardian
- Patients with mild paramorphisms not associated with functional limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatmentPatients are provided with physiotherapy support and the provision of prostheses with the goal of ensuring as much walking functionality as possible. | Other | Children and adolescent with lower limb deformities |
| Single or multi-stage surgeryCorrection 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 or surgery | Children and adolescent with lower limb deformities |
| AmputationLimb surgery, whether or not associated with realignment or soft-tissue surgery, is performed, aimed at providing the maximum possible walking function through a prosthesis. | Procedure or surgery | Children and adolescent with lower limb deformities |
Primary outcome
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)
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)
Clinical examination with complete assessment of lower limbs
Time frame: At baseline (day 0)
Full assessment of parameters about lower limb alignment
Clinical examination with complete assessment of lower limbs
Time frame: After 1 year
Full assessment of parameters about lower limb alignment
Mental Health
Time frame: At baseline (day 0)
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Mental Health
Time frame: After 1 year
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- BackgroundHerring J, Tachdjian's Pediatric Orthopaedics: From the Texas Scottish Rite Hospital for Children, 6th edition. Elsevier, 2020.
- BackgroundSabharwal S. Pediatric Lower Limb Deformities: Principles and Techniques of Management. Springer 2015.
- Background: PubMed 32099279Gupta 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.
- Background: PubMed 33792793Chhina 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.
- Background: PubMed 20739904Iobst 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.
- BackgroundFrizziero 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: PubMed 38003894Blobel 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.
- Background: PubMed 1934735Stuberg 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.
- Background: PubMed 5820785Beighton P, Horan F. Orthopaedic aspects of the Ehlers-Danlos syndrome. J Bone Joint Surg Br. 1969 Aug;51(3):444-53. No abstract available.
- Background: PubMed 30882054Dodwell 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.
- Background: PubMed 31078660Harris 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.
- Individual participant dataSharing planned: Undecided
Related trials for Deformity of Limb
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
RecruitingObservational study
Study of Proteus Syndrome and Related Congenital Disorders
Proteus Syndrome, PIK3CA Related Overgrowth Spectrum
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Enrolling by invitationObservational study
Advanced Ultrasound Signal Processing of Suspicious Breast Images
Breast Cancer, Breast Cyst
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro Depaoli, MD contact
Pierfrancesco Costici, MD principal investigator
Ospedale Pediatrico Bambin Gesù
Giorgio Marrè Brunenghi, MD principal investigator
Istituto Giannina Gaslini
Fabio Verdoni, MD principal investigator
Galeazzi Orthopedic Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deformity of Limb, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Trisolino, MD (0516366 ext. 484, giovanni.trisolino@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Outcomes Data Collection Instrument (time frame: At baseline (day 0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519175, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.