Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519175
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-06
Brief Title:
Study of Infantile Lower Limb Malformations and Deformities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observational Retrospective and Prospective Study of Infantile Lower Limb Malformations and Deformities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMEDIA-I
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None