A Multi-Center 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
- 200
- 试验地点
- 3
- 主要终点
- Neck Disability Index
研究概览
简要总结
This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that 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
- •Over the age of 21 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, as applicable.
排除标准
- •Moderate to advanced spondylosis
- •Diagnosis of osteoporosis
- •Active systemic infection or infection at the operative site
- •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
- •Currently a prisoner
研究组 & 干预措施
Prospective
All patients for whom the decision has been made to have the Synergy Disc implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol, per country-specific requirements, will be enrolled in the prospective portion of this protocol.
干预措施: Synergy Cervical Disc System (Device)
Retrospective
Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted will be eligible for inclusion in the retrospective data collection; a waiver of consent, or informed consent, for retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations as applicable.
干预措施: Synergy Cervical Disc System (Device)
结局指标
主要结局
Neck Disability Index
时间窗: 12 months
\>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline
Device Related or Device Procedure Related Adverse Events
时间窗: 12 months
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event
次要结局
- Patient Satisfaction(6 weeks, 3 months, 6 months, 12 months, annually post operatively)
- Nurick's Criteria(pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively)
- Neurologic Function(6 weeks, 3 months, 6 months, 12 months, annually post operatively)
- Visual Analog (VAS) pain(pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively)
- Odom's Criteria(6 weeks, 3 months, 6 months, 12 months, annually post operatively)