Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05245617
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2022-02-09
Brief Title:
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
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 Plating System JPS for the Treatment of Congenital Deformities and Fractures in Lower Limb of Pediatric and Adult Patients
Status:
COMPLETED
Status Verified Date:
2024-06
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:
JPS
Brief Summary:
Orthofix Srl put the JPS on the European market 2019 by the mean of a pre-market clinical evaluation made under the Medical Device Directive MDD requirements that were based on the analysis of the scientific literature of equivalent devices
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 JPS in a representative population of Patients and users
The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JPS with real-word-evidence clinical data in order to confirm the benefitrisk ratio of this medical device and to keep the CE mark under Medical Device Regulation MDR requirements
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 JPS in a representative population of Patients and users
The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JPS with real-word-evidence clinical data in order to confirm the benefitrisk ratio of this medical device and to keep the CE mark under Medical Device Regulation MDR requirements
Detailed Description:
One selected site that is experienced in the treatment of pediatric and adult patients with bone deformities and fractures where the usage of JPS is already part of the normal clinical practice will participate in this study Investigator will provide data for a maximum of 40 JPS implant cases satisfying inclusion and exclusion criteria predicted drop out rate is 10 that will contribute for at least 30 cases treated by JPS note that some patients may contribute for more than one JPS case according to how many JPS implants were received
For retrospective study cohort who has previously had JPS implanted and follow-up assessment and JPS removal is done the investigators shall purely collect clinical data from the medical record of the subjects concerning the screening criteria the surgery MD application and 4 following events hospital discharge first post-application control bone consolidation assessment and device removal Data from patients observation are collected according to the site standard-of-care
Patients who are prospectively enrolled in the study and have undergone JPS implantation will have follow-up assessments as described on Table 102 or until patient withdrawal
The patient data will be systematically collected by the investigator in eCRF As per CIP the subjects will not undergo additional visit nor non-invasive invasive or burdensome procedures additional to those performed under the normal clinical practice
For retrospective study cohort who has previously had JPS implanted and follow-up assessment and JPS removal is done the investigators shall purely collect clinical data from the medical record of the subjects concerning the screening criteria the surgery MD application and 4 following events hospital discharge first post-application control bone consolidation assessment and device removal Data from patients observation are collected according to the site standard-of-care
Patients who are prospectively enrolled in the study and have undergone JPS implantation will have follow-up assessments as described on Table 102 or until patient withdrawal
The patient data will be systematically collected by the investigator in eCRF As per CIP the subjects will not undergo additional visit nor non-invasive invasive or burdensome procedures additional to those performed under the normal clinical practice
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