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

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

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 Overview

• Status: Recruiting
• Conditions: Trauma; Deformity; Defect, Congenital
• Intervention / Treatment: Device: JuniOrtho™ Plating System™

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 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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Orthofix Clinical Affairs Department; Phone Number: (+39) 045 6719 000; Email: ClinicalAffairs@orthofix.it

Study Locations

• Germany
  • Ruhr
    • Wetter, Ruhr, Germany, 58300
      • Recruiting
      • Orthopädische Klinik Volmarstein
      • Contact: Benedikt Leidinger, M.D.; Phone Number: (+49) 0 23 35 - 639 40 20; Email: Leidinger@esv.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study will be conducted only on patients with a regular indication for JPS JuniOrtho Plating System as per IFU: the system is intended in pediatric (excluding newborns) and small stature adult patients. Pediatric patients include infants (greater than 1 month to 1 years of age), children (greater than 1 to 12 years of age), adolescents (greater than 12 to 18 years of age) and appropriate adults (where according to investigator assessment, the JPS plates fit the treated bone anatomy).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

JPS treated patients; This grup will include all patients with regular indication for JPS: system is intended in pediatric (excluding newborns) and small stature adult patients. Pediatric patients include infants (greater than 1 month to 1 years of age), children (greater than 1 to 12 years of age), adolescents (greater than 12 to 18 years of age) and appropriate adults (where according to investigator assessment, the JPS plates fit the treated bone anatomy).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Orthofix s.r.l.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Fracture; Tibia; Femur; Congenital; Defromity; Plate
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: OCI_2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No