Trauma Clinical Trial
— JPSOfficial 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
NCT number | NCT05245617 |
Other study ID # | OCI_2102 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 16, 2022 |
Est. completion date | May 21, 2024 |
Verified date | June 2024 |
Source | Orthofix s.r.l. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 21, 2024 |
Est. primary completion date | May 21, 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Orthopädische Klinik Volmarstein | Wetter | Ruhr |
Lead Sponsor | Collaborator |
---|---|
Orthofix s.r.l. |
Germany,
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
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) |
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