Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System (Implant and Instrumentation) - A Retrospective Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Performance: Fracture Healing
研究概览
简要总结
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Reconstruction System (implants and instrumentation) when used for temporary internal fixation and stabilization of fractures during the normal healing process.
The primary objective is the assessment of performance by analyzing fracture healing.
The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.
详细描述
The Reconstruction System is especially used to stabilize pelvic ring and acetabulum fractures. One site will be involved in this study. The aim is to include a maximum of 83 consecutive series cases who received the Zimmer Reconstruction System at the Azienda Ospedaliero Universitaria Senese (Siena, Italy) between 2010 and 2018. All potential study subjects will be required to participate to the Informed Consent process.
Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected retrospectively.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having received the Zimmer Reconstruction System for temporary internal fixation and stabilization of fractures during the normal healing process
排除标准
- •Off-label use
- •Patients under the age of 18
- •Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
- •Infection
- •Metal sensitivity or intolerance
- •Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
- •Sternal or spinal fractures
- •Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
- •Patients with inadequate soft tissue coverage at the implant site
研究组 & 干预措施
Patients implanted with the Zimmer Reconstruction System
Patients implanted with the Zimmer Reconstruction System
结局指标
主要结局
Performance: Fracture Healing
时间窗: Mean time of 1.99 years after the surgery
Performance will be assessed by analyzing fracture healing radiographically by X-rays.
次要结局
- Product Safety(Mean time of 1.99 years after the surgery)
- Harris Hip Score(Mean time of 1.99 years after the surgery)