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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: JuniOrtho™ Plating System™ (Device)
结局指标
主要结局
Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs)
时间窗: Up to 18 months from surgery (at device removal)
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.
Percentage (%) of Subjects With at Least One Medica Device Deficiencies (MDDs)
时间窗: Up to 18 months from surgery (at device removal)
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.
次要结局
- 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))