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

Trauma Clinical Trial

— JPS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05245617
• Other study ID #: OCI_2102
• Status: Active, not recruiting
• Start date: November 16, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Orthofix s.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 10.2, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Defect, Congenital
• Deformity
• Trauma

Intervention

Device:
• JuniOrtho™ Plating System™
The patient underwent surgery for the application of JPS for treatment of deformity or traumatic fracture.

Locations

Country	Name	City	State
Germany	Orthopädische Klinik Volmarstein	Wetter	Ruhr

Sponsors (1)

Lead Sponsor	Collaborator
Orthofix s.r.l.

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Islam SU, Henry A, Khan T, Davis N, Zenios M. The outcome of paediatric LCP hip plate use in children with and without neuromuscular disease. Musculoskelet Surg. 2014 Dec;98(3):233-9. doi: 10.1007/s12306-013-0308-6. Epub 2013 Dec 3. — View Citation

Joeris A, Audige L, Ziebarth K, Slongo T. The Locking Compression Paediatric Hip Plate: technical guide and critical analysis. Int Orthop. 2012 Nov;36(11):2299-306. doi: 10.1007/s00264-012-1643-1. Epub 2012 Aug 26. — View Citation

Masquijo JJ. Percutaneous plating of distal tibial fractures in children and adolescents. J Pediatr Orthop B. 2014 May;23(3):207-11. doi: 10.1097/BPB.0000000000000036. — View Citation

Sidler-Maier CC, Reidy K, Huber H, Dierauer S, Ramseier LE. LCP 140 degrees Pediatric Hip Plate for fixation of proximal femoral valgisation osteotomy. J Child Orthop. 2014 Feb;8(1):29-35. doi: 10.1007/s11832-014-0550-y. Epub 2014 Jan 28. — View Citation

Xu Y, Bian J, Shen K, Xue B. Titanium elastic nailing versus locking compression plating in school-aged pediatric subtrochanteric femur fractures. Medicine (Baltimore). 2018 Jul;97(29):e11568. doi: 10.1097/MD.0000000000011568. — View Citation

Zheng P, Yao Q, Xu P, Wang L. Application of computer-aided design and 3D-printed navigation template in Locking Compression Pediatric Hip PlateTauMu placement for pediatric hip disease. Int J Comput Assist Radiol Surg. 2017 May;12(5):865-871. doi: 10.1007/s11548-017-1535-3. Epub 2017 Feb 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage (%) of subjects with at least one serious/not serious adverse event certainly related or possibly related to JPS (ADEs)	The measurement is used to asses the safety profile of the JPS system.	Up to 18 months from surgery (at device removal)
Primary	Percentage (%) of MD Deficiencies (MDDs)	The measurement is used to asses the safety profile of the JPS system.	Up to 18 months from surgery (at device removal)
Secondary	Percentage (%) of subjects that reached a satisfactory bone consolidation according to investigator's opinion	The measurement is used to asses the clinical performance of the JPS system.	Up to 18 months from surgery (at device removal)
Secondary	Percentage (%) of subjects that maintained bone correction alignment according to investigator's opinion	The measurement is used to asses the clinical performance of the JPS system.	Up to 18 months from surgery (at device removal)