Status:
COMPLETED
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Lead Sponsor:
Orthofix s.r.l.
Conditions:
Deformity
Defect, Congenital
Eligibility:
All Genders
1+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05245617
Start Date
November 16 2022
End Date
April 19 2024
Last Update
January 8 2026
Active Locations (1)
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1
Orthopädische Klinik Volmarstein
Wetter, Ruhr, Germany, 58300