Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05612139
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2022-11-03
Brief Title:
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
Sponsor:
Orthofix srl
Organization:
Orthofix srl
Study Overview
Official Title:
A Single Center Post-market Clinical Follow-up PMCF Observational Study Evaluating the Clinical Performance and the Safety Profile of the JuniOrtho Telescopic Intramedullary Nail JTIN for the Treatment of Pediatric Patients Suffering From Osteogenesis Imperfecta
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JTIN
Brief Summary:
This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN
The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JTIN with Real World Evidence clinical data in a real-life surgical setting in order to confirm the benefitrisk ratio of this medical device and to keep the CE mark under Medical Device Regulation MDR requirements One selected site experienced in the treatment of pediatric patients with OI where the usage of JTIN is already part of the normal clinical practice will participate in this study
The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JTIN with Real World Evidence clinical data in a real-life surgical setting in order to confirm the benefitrisk ratio of this medical device and to keep the CE mark under Medical Device Regulation MDR requirements One selected site experienced in the treatment of pediatric patients with OI where the usage of JTIN is already part of the normal clinical practice will participate in this study
Detailed Description:
One selected site experienced in the treatment of pediatric patients with OI where the usage of JTIN is already part of the normal clinical practice will participate in this study Investigator will screen patients treated or planned to be treated with JTIN to verify inclusion and exclusion criteria to achieve the enrollment of 25 cases With lost to follow-up percentage estimated at 20 this will lead to a total of 20 evaluable cases ie 20 implanted JTIN some patients may contribute for more than one implant Patients are prospectively and retrospectively enrolled in the study they may have undergone JTIN implantation from the 1st of January 2022
Enrolled patients since this study is non-interventional and observational will follow the standard medical practice of the site no requirements regarding the treatment of patients will be imposed on the site or Principal Investigator and the Sponsor will not in any manner influence the treatment decisions Data of enrolled subjects will be collected for this study up to 1 year from surgery
The hospital standard care usually but not exclusively includes surgery discharge and plaster removal visits and then 3 other follow up visits up to 1 year from surgery see Visits and Assessments Schedule Visits frequency is estimated as average of the site normal clinical practice actual visit timing for each patient will be performed according to investigators and hospital staff evaluation
The patient data will be systematically collected by the investigator in eCRF
Enrolled patients since this study is non-interventional and observational will follow the standard medical practice of the site no requirements regarding the treatment of patients will be imposed on the site or Principal Investigator and the Sponsor will not in any manner influence the treatment decisions Data of enrolled subjects will be collected for this study up to 1 year from surgery
The hospital standard care usually but not exclusively includes surgery discharge and plaster removal visits and then 3 other follow up visits up to 1 year from surgery see Visits and Assessments Schedule Visits frequency is estimated as average of the site normal clinical practice actual visit timing for each patient will be performed according to investigators and hospital staff evaluation
The patient data will be systematically collected by the investigator in eCRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None