Clinical Outcome Measure at Stryker Spine: COMPASS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,222
- 试验地点
- 7
- 主要终点
- S-S-102-C
研究概览
简要总结
This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).
详细描述
Stryker Spine has a broad portfolio of spinal devices used to stabilize the spine. This PMCF study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. Four protocols have been designed to aid in this process, a master and three sub-protocols. The sub-protocols are based on body region and indication:
- S-S-102-A Cervical: Interbody Devices (IBDs), Vertebral Body Replacement Devices (VBRs), Internal Fixation Devices, and Vitoss
- S-S-102-B Thoracolumbar: IBDs, VBRs, Internal Fixation Devices, and Vitoss
- S-S-102-C Adult Spinal Deformities: IBDs, Internal Fixation Devices, and Vitoss Each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and SAPs. Safety data will be collected throughout the study.
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
- •To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
排除标准
- •The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
结局指标
主要结局
S-S-102-C
时间窗: Baseline through 24-months post-op.
Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).
S-S-102-A
时间窗: Baseline through 24-months post-op.
Mean change in the subject's Neck Disability Index (NDI) score.
S-S-102-B
时间窗: Baseline through 24-months post-op.
Mean change in the subject's Oswestry Disability Index (ODI) score.
次要结局
- S-S-102-A(Surgery through 24-months post-op.)
- S-S-102-B(Surgery through 24-months post-op.)
- S-S-102-C(Surgery through 24-months post-op.)