Clinical trial NCT05245617: Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deformity
Defect, Congenital
Trauma
Keywords: Femur
Tibia
Congenital
deformity
Plate
Fracture
Lead sponsor: Orthofix s.r.l.
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

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 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.

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.

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.

Primary outcomes:
measure: Percentage (%) of subjects with at least one serious/not serious adverse event certainly related or possibly related to JPS (ADEs)
timeFrame: Up to 18 months from surgery (at device removal)
measure: Percentage (%) of MD Deficiencies (MDDs)
timeFrame: Up to 18 months from surgery (at device removal)
Secondary outcomes:
measure: Percentage (%) of subjects that reached a satisfactory bone consolidation according to investigator's opinion
timeFrame: Up to 18 months from surgery (at device removal)
measure: Percentage (%) of subjects that maintained bone correction alignment according to investigator's opinion
timeFrame: Up to 18 months from surgery (at device removal)
Other outcomes:
Locations:
city: Wetter
country: Germany
facility: Orthopädische Klinik Volmarstein
state: Ruhr
Study officials:
affiliation: Orthopädische Klinik Volmarstein
name: Benedikt Leidinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
citation: 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.
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.