Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical outcome via neck disability index (NDI)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.
详细描述
This is a retrospective, prospective, post-market, observational, single-center, single surgeon study evaluating the use of the SeaSpine Shoreline device. Patients will be identified by the Investigator as needing, or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Appropriate patient, as determined by the Investigator, scheduled for an elective cervical spine fusion to treat adjacent level cervical disc herniation or degeneration resulting in cervical radiculopathy or myelopathy
- •At least 18 years of age
- •Failure of nonoperative care
- •Previous anterior cervical plating
- •Psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements
排除标准
- •Pregnancy or anticipated to become pregnant during the course of the study
- •No previous cervical spine surgery
- •Non-instrumented cervical fusion
- •Cervical fusion with separate plate fixation
- •Unwilling or unable to sign consent
- •Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
- •Currently a prisoner
结局指标
主要结局
Clinical outcome via neck disability index (NDI)
时间窗: 12 months post surgery
Standard of care patient reported neck disability index (NDI) will be used to evaluate patient pain and quality of life. On a vertical scale of 0 to 5 with a score of 0 meaning neck pain (if any) does not interfere with life activities and 5 meaning neck pain strongly interferes with life activities. A low score means a better clinical outcome. A high score means a worse clinical outcome.
Cervical fusion assessed via CT scan
时间窗: 12 months post surgery
Motion, bridging on radiograph, and bridging bone on CT scan
Clinical outcome via Dysphagia score
时间窗: 12 months post surgery
Standard of care patient reported dysphagia score will be used to evaluate patient inability or difficulty swallowing. On a scale of 0 to 4 with a score of 0 meaning no difficulty and 4 meaning severe problem. A low score means a better clinical outcome. A high score means a worse clinical outcome.
Clinical outcome via neck visual analog scale (VAS)
时间窗: 12 months post surgery
Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome.
次要结局
未报告次要终点