PMCF Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System Applied for Diaphyseal, Proximal Humerus and Proximal Tibia Fractures (Implants and Instrumentation) - A Retro- and Prospective Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 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, retro- and prospective, 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 Zimmer® Plates and Screws System (implants and instrumentation) when used to stabilize diaphyseal, proximal humerus and proximal tibia fractures.
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 Zimmer® Plates and Screws System consists of temporary internal fixation devices comprised of plates and screws that provide management of fractures through interfragmentary compression and bone plating. In this study, the focus is on the Zimmer® Plates and Screws System used to stabilize diaphyseal, proximal humerus and proximal tibia fractures.
One site will be involved in this study. The aim is to include a maximum of 112 consecutive series cases who received the Zimmer® Plates and Screws System at the Istituto Ortopedico Rizzoli (Bologna, Italy) between 2008 and 2018. All potential study subjects will be required to participate in the Informed Consent process.
Baseline data from the preoperative, intraoperative, immediate post-operative and last consultation visit at minimum 6 months post-operative will be available in medical notes and collected retrospectively. During a follow up phone call the subject will be asked to complete questionnaires and a clinical assessment of the fracture healing. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having received one of the plates belonging to the Zimmer® Plates and Screws System, designed for temporary internal fixation to stabilize fractures during the normal healing process. In this study we will collect data specifically on Zimmer® Plates and Screws System plates belonging to the Diaphysis, Proximal Humerus and Proximal Tibia groups.
排除标准
- •Off-label use
- •Patients under the age of 18
- •Prisoners
- •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
结局指标
主要结局
Performance: Fracture Healing
时间窗: At last consultation visit either at minimum 6 months post-operative by radiographic assessment or, if no x-rays available, by clinical assessment at the follow-up phone call at minimum 1 year postoperative.
Performance will be assessed by analyzing fracture healing radiographically or clinically. Timepoints at which the data will be collected will be summarized through means.
次要结局
- Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)(At operative evaluation, immediate post-operative evaluation, last consultation visit at minimum 6 months post-operative and at the follow-up phone call at minimum 1 year postoperative.)
- Tegner Lysholm Knee Score (Proximal Tibia)(Final follow-up visit at minimum 1 year postoperative.)
- Oxford Shoulder Score (OSS) (Proximal Humerus)(Final follow-up visit at minimum 1 year postoperative.)
- EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis)(Final follow-up visit at minimum 1 year postoperative.)