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| Name | Class |
|---|---|
| Ospedale Pediatrico Bambino Gesù | UNKNOWN |
| Istituto Giannina Gaslini | OTHER |
| Galeazzi Orthopedic Institute | UNKNOWN |
| Istituto Nazionale Tumori Regina Elena |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children and adolescent with lower limb deformities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with congenital or acquired deformity of one or both lower limb diagnosed before skeletal maturity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Trisolino, MD | Contact | 0516366 | 484 | giovanni.trisolino@ior.it |
| Alessandro Depaoli, MD | Contact | alessandro.depaoli@ior.it |
| Name | Affiliation | Role |
|---|---|---|
| Pierfrancesco Costici, MD | Ospedale Pediatrico Bambin Gesù | Principal Investigator |
| Giorgio Marrè Brunenghi, MD | Istituto Giannina Gaslini | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 32099279 | 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. | |
| 33792793 |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| D012847 | Single Person |
| D000671 | Amputation, Surgical |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
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| UNKNOWN |
| Policlinico San Matteo | UNKNOWN |
| Istituto Clinico Humanitas | OTHER |
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| 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. |
|
| 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 |
| Istituto Giannina Gaslini | Not yet recruiting | Genova | Italy |
|
| Galeazzi Orthopedic Institute | Not yet recruiting | Milan | Italy |
|
| Policlinico San Matteo | Not yet recruiting | Pavia | Italy |
|
| Istituto Nazionale Tumori Regina Elena | Not yet recruiting | Roma | Italy |
|
| Ospedale Pediatrico Bambino Gesù | Not yet recruiting | Roma | Italy |
|
| Istituto Clinico Humanitas | Not yet recruiting | Rozzano | Italy |
|
| 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. |
| 20739904 | 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. |
| 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. |
| 38003894 | 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. |
| 1934735 | 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. |
| 5820785 | 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. |
| 30882054 | 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. |
| 31078660 | 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. |
| D011154 |
| Population Characteristics |
| D012959 | Socioeconomic Factors |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |