A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 20
- 主要终点
- Primary Safety Assessment: Device or procedure related adverse events
研究概览
简要总结
This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries and/or disorders following the local medical standard of care. The clinical data generated from this study will support compliance to global regulatory requirements including but not limited to the European Medical Device Regulation (EU MDR) for the applicable devices.
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
- •Patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing Orthofix Spine devices.
- •Patient is 18 years or older at the time of surgery.
- •Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study.
- •Patient is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
- •Note: For retrospective segment of the study: A waiver of consent for retrospective data collection is in place OR an informed consent is obtained from the participating patient prior to data collection as required by local regulations.
- •Exclusion criteria:
- •Patient may be excluded from study participation if there are other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.
排除标准
- 未提供
结局指标
主要结局
Primary Safety Assessment: Device or procedure related adverse events
时间窗: Pre-Operative to up to 10-years Post-Operative
Evaluation of device related or procedure related adverse events
Primary Effectiveness Assessments: Fusion status measured radiographs
时间窗: Intra-operative to up to 10-years Post-Operative
Fusion status measured utilizing quantitative and qualitative radiographic assessments as applicable
Primary Effectiveness Assessment
时间窗: Intra-operative to up to 10-years Post-Operative
Improvement in function as measured with Neck Disability Index (NDI) or Oswestry Disability Index (ODI). NDI includes 4 items that relate to subjective symptomatology (pain severity, headache, concentration, sleeping) and 6 items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading). Each item is scored from 0 to 5, with higher scores corresponding to greater disability. A total NDI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the NDI score ranges from 0 to 100. The ODI was developed as a specific outcomes tool for subjects suffering from back pain. The questionnaire scores 10 aspects of the subject's home and work life and analgesic use. The disability index is then calculated as a percentage with a high percentage indicating a high level of disability.
次要结局
- Secondary Effectiveness Assessments: Patient Satisfaction(Pre-Operative to up to 10-years Post-Operative)
- Secondary Safety Assessments: Additional required medical treatments and/or supplemental surgical procedure(Pre-Operative to up to 10-years Post-Operative)
- Secondary Effectiveness Assessments: Work and Activity status(Pre-Operative to up to 10-years Post-Operative)
- Secondary Effectiveness Assessments: Changes in neurological function(Pre-Operative to up to 10-years Post-Operative)
- Secondary Effectiveness Assessments: Duration of Hospital stay(Pre-Operative to up to 10-years Post-Operative)
- Secondary Effectiveness Assessments: Quality of Life assessment(Pre-Operative to up to 10-years Post-Operative)
- Secondary Effectiveness Assessments: Duration of Surgery(Pre-Operative to up to 10-years Post-Operative)
- Secondary Safety Assessments: Device and/or procedure-related deficiencies(Pre-Operative to up to 10-years Post-Operative)