A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or above at the time of the surgery. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
- •Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression:
- •herniated disc and/or osteophyte formation Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.) Failed a minimum of 6 weeks conservative treatment Written informed consent given by subject.
排除标准
- •Moderate to advanced spondylosis Diagnosis of osteoporosis Active systemic infection or infection at the operative site Pregnancy Marked cervical instability on lateral, coronal, or flexion/extension radiographs Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level Severe pathology of the facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)-
研究组 & 干预措施
Prospective
All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements.
干预措施: Synergy Cervical Disc system (Device)
Retrospective
Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations.
干预措施: Synergy Cervical Disc system (Device)
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: 12 months
Neck disability Index improvement of \>15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score.
Device Related or Device Procedure Related Adverse Events
时间窗: 12 months
Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
次要结局
- Nurick's Criteria(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
- Patient Satisfaction(6 week, 3 month, 6 month, 12 month, 24 month)
- Motor and Sensory Function in the Arm(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
- Neck and Arm Pain Measurement(pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month)
- Odom's criteria(6 week, 3 month, 6 month, 12 month, 24 month)