Observational Retrospective Multicentric Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices in Patients Who Have Needed Bone Stabilization or Bone Fixation for Fractures of the Long Bones, Vertically Stable Pelvic Fractures, or Vertically Unstable Pelvic Fractures as a Treatment Adjunct in Daily Practice: GALAXY Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 6
- 主要终点
- The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices.
研究概览
简要总结
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice. The study will be conducted in three sites located in Italy considered reference sites for the treatment of adults and paediatric patients with fractures of the long bones, vertically stable pelvic fractures, or vertically unstable pelvic fractures as a treatment adjunct, where the usage of GALAXY FIXATION™ System and Orthofix implantable devices were part of the normal clinical practice. The participant investigators will retrospectively include a maximum of 118 patients in which GALAXY FIXATIONTM System and Orthofix implantable devices were used. No diagnostic or therapeutic intervention outside routine clinical practice will be applied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 29 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient directly or indirectly (through a respondent) expressed his willingness to participate in the Study by signing and dating informed consent.
- •Patient who had a regular indication for the following surgical intervention with the GALAXY FIXATION™ System and Orthofix implantable devices according to manufacturer's IFUs:
- •fractures of the long bones or;
- •Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct.
- •Patients equal or older than 29 days.
- •Patients who had a regular indication for external fixation according to the investigator criteria.
- •Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study
排除标准
- •The patient is participating in other clinical studies or did he/she participate in the 3 months before signing the informed consent in other clinical studies.
- •The patient needed the application of or had already in-situ concomitant devices that couldn't be safely removed (except for permitted concomitant devices).
- •The patient was treated with more than one GALAXY FIXATION™ System or non Orthofix implantable devices.
- •Patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions.
- •Patient who had previous infections in the fracture area.
- •Patients who had malignancy in the fracture area.
- •Patients who had neuromuscular deficit or any other conditions that could influence the healing process.
- •Patients who had suspected or documented metal sensitivity reactions as it could result in a treatment failure in the intended population
结局指标
主要结局
The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices.
时间窗: average of 2 months
It will be assessed by the percentage of patients in which GALAXY FIXATION™ System and Orthofix implantable devices have guaranteed the maintenance of reduction in temporary stabilization and the achievement of bone union in definitive fixation until the end of treatment.
次要结局
未报告次要终点