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Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb

NCT05245617 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-01-30

Study results available
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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.

Conditions

  • Deformity
  • Defect, Congenital
  • Trauma

Interventions

DEVICE

JuniOrtho™ Plating System™

The patient underwent surgery for the application of JPS for treatment of deformity or traumatic fracture.

Sponsors & Collaborators

  • Orthofix s.r.l.

    lead INDUSTRY

Principal Investigators

  • Benedikt Leidinger, MD · Orthopädische Klinik Volmarstein

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2024-04-19
Completion
2024-04-19

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245617 on ClinicalTrials.gov