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DeformityJPSNCT05245617

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

An observational study of Deformity and Defect, Congenital, run by Orthofix s.r.l. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 month and older
Conditions the study is for
Deformity, Defect, Congenital, Trauma
What is being tested?
JuniOrtho™ Plating System™
Type of treatment
Medical device
How many people
30 participants
Where
1 siteGermany
Study dates
16 Nov 2022to 19 Apr 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Orthopädische Klinik Volmarstein

    Wetter, Ruhr, 58300

Other trials in Germany

About this study

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

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.

Read 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 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.

Being tested
JuniOrtho™ Plating System™
Keywords
Femur, Tibia, Congenital, deformity, Plate, Fracture
Medical subject headings
Congenital Abnormalities, Wounds and Injuries, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JuniOrtho™ Plating System™Device

    Also called JPS

    The patient underwent surgery for the application of JPS for treatment of deformity or traumatic fracture.

Study groups in NCT05245617
Study groupRoleWhat they receive
JPS treated patientsThis 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).
Receives: Device: JuniOrtho™ Plating System™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs)

    Percentage of subjects who experience at least one adverse event (serious or non-serious) that the investigator judges as certainly or possibly related to the JPS system (ADEs). This outcome is used to assess the safety profile of the JPS system.

    Measured: Up to 18 months from surgery (at device removal)

  2. Percentage (%) of Subjects With at Least One Medica Device Deficiencies (MDDs)

    Percentage of subjects who experienced at least one medical device deficiency (MDD) i.e., any inadequacy, malfunction, or nonconformance of the investigational device or its accessories, during the defined observation window. This outcome is used to asses the safety profile of the JPS system.

    Measured: Up to 18 months from surgery (at device removal)

Secondary outcomes (2)

  1. Percentage (%) of Subjects That Reached a Satisfactory Bone Consolidation According to Investigator's Opinion

    Percentage of subjects who achieved satisfactory bone consolidation, as judged by the investigator per protocol-defined criteria, up to the specified assessment time point. This outcome is used to asses the clinical performance of the JPS system.

    Measured: Up to 18 months from surgery (at device removal)

  2. Percentage (%) of Subjects That Maintained Bone Correction Alignment According to Investigator's Opinion

    Percentage of subjects who maintained bone correction alignment, as assessed by the investigator per protocol-defined criteria, up tp the specified follow-up time point. Note: This outcome is calculated only for the subgroup "JPS-Treated Patients for Deformity Correction.", that is the only patients that present a correction alignment. This outcome is used to asses the clinical performance of the JPS system.

    Measured: Up to 18 months from surgery (at device removal)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start16 Nov 2022
  3. Primary completion19 Apr 2024
  4. Study completion19 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05245617
Sponsor's protocol ID
OCI_2102
Acronym
JPS
Status last verified
Jan 2026
First submitted
9 Feb 2022
Last updated
30 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22923267

  • 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.

    PubMed 24488843

  • 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.

    PubMed 24500423

  • 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.

    PubMed 30024559

  • 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.

    PubMed 24297691

  • 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.

    PubMed 28190127

Questions about this trial

What is this clinical trial studying?

An observational study of Deformity and Defect, Congenital, run by Orthofix s.r.l. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs) (time frame: Up to 18 months from surgery (at device removal)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05245617, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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