At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating JuniOrtho™ Plating System™ for Deformity and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed 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 benefit/risk ratio of this medical device and to keep the CE mark under Medical Device Regulation (MDR) requirements.
Study Details
Timeline
Interventions
The patient underwent surgery for the application of JPS for treatment of deformity or traumatic fracture.