Cervical Interbody Fusion Device Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 at 1 year post-operative from a pre-operative baseline
研究概览
简要总结
The registry has been designed as a prospective, observational program for patients undergoing anterior cervical discectomy and fusion (ACDF) procedures treated with TIDAL cervical interbody fusion device. The ultimate goal of the study is to aid in the development of treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the device in either an inpatient or outpatient facility.
详细描述
The registry is design to collect data prospectively on patients undergoing spinal fusion using the TIDAL cervical interbody fusion device. Patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. Data will be collected at recommended time points based on the standards of care of the participating sites. The registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered.
Follow up visits will be defined by the treating physicians based on their standard practice. Typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neck and arm pain for a minimum of 6 weeks before surgery that is recalcitrant to nonoperative treatment modalities, such as physical therapy, reduced activities, and anti-inflammatory medications.
- •Radiographic evidence of cervical disc disease that is documented on dynamic radiographs and magnetic resonance imaging (MRI).
排除标准
- •Medical condition that required medication, such as steroids or nonsteroidal anti-inflammatory medications, that could interfere with fusion.
- •There are no restrictions on sex or ethnicity.
结局指标
主要结局
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 at 1 year post-operative from a pre-operative baseline
时间窗: 1 year
ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability \>34 Complete disability
Change in VAS Pain at 1 year post-operative from a pre-operative baseline
时间窗: 1 year
VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'
次要结局
- Improvement in patient reported short-form 36 (SF36) scores at 1 year post-operative from a pre-operative baseline(1 year)
- Rate of Successful Fusion Based on Radiological Assessment at 1 Year Post-op(1 year)