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

NCT05245617 | Completed Results

• 1 other identifier: OCI_2102
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Deformity; Defect, Congenital; Trauma

Keywords

Femur; Tibia; Congenital; deformity; Plate; Fracture

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 18 months from surgery (at device removal)

• 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.

  Up to 18 months from surgery (at device removal)

Secondary Outcomes (2)

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

  Up to 18 months from surgery (at device removal)

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

  Up to 18 months from surgery (at device removal)

Study Arms (1)

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™

Interventions

JuniOrtho™ Plating System™ DEVICE

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

Also known as: JPS

JPS treated patients

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (1)

Orthopädische Klinik Volmarstein

Wetter, Ruhr, 58300, Germany

Location

Related Publications (6)

• 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.

  PMID: 22923267 BACKGROUND

• 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.

  PMID: 24488843 BACKGROUND

• 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.

  PMID: 24500423 BACKGROUND

• 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.

  PMID: 30024559 BACKGROUND

• 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.

  PMID: 24297691 BACKGROUND

• 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.

  PMID: 28190127 BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities; Wounds and Injuries; Fractures, Bone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Clinical Affairs Operations team
• Organization: Orthofix s.r.l.

clinicalaffairs@orthofix.it

+39 045 6719000

Study Officials

• Benedikt Leidinger, MD

  Orthopädische Klinik Volmarstein

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: November 16, 2022
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)