N/A
N=30
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Deformity · Defect, Congenital · Trauma
Bottom Line
View on ClinicalTrials.gov: NCT05245617 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Jan 2026
Primary outcome: Primary: Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs) — 3.3 percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- JuniOrtho™ Plating System™ (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Orthofix s.r.l.
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs) |
3.3 | — |
| PRIMARY Percentage (%) of Subjects With at Least One Medica Device Deficiencies (MDDs) |
70.0 | — |
| SECONDARY Percentage (%) of Subjects That Reached a Satisfactory Bone Consolidation According to Investigator's Opinion |
96.7 | — |
| SECONDARY Percentage (%) of Subjects That Maintained Bone Correction Alignment According to Investigator's Opinion |
96.3 | — |
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.
Eligibility Criteria
Inclusion Criteria: a patient will be eligible for inclusion in the study if:
- had a regular indication for surgical intervention with JPS according to the manufacturer's IFU;
- underwent a surgery for bone deformity correction or trauma reconstruction of the lower extremities performed by JPS;
- the clinical data registered in her/him patient chart are sufficient to assess the safety and efficacy endpoint of the study;
- patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF) [applicable for the prospective group of patients]
- patient is willing and able to participate in the prospective data collection and comply with the protocol requirements;
Note: for the retrospective group of patients to whom all interventions and control visits were already done, a waiver of consent for retrospective data collection to be requested.
Exclusion Criteria: a Patient will be excluded from participation in the study if he/she:
- had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet;
- had/has a concomitant not permitted device which cannot be safely removed;
- patient for whom there are other concurrent medical or other conditions that in opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.
Data sourced from ClinicalTrials.gov (NCT05245617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.