A Multicenter, Retrospective Analysis to Evaluate Radiographic Outcomes and Safety Profiles Along Prospective Follow-Up Periods for Patients Implanted With 2 Levels of Prodisc® C Vivo Devices.
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Centinel Spine
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of the Occurrence of Secondary Surgical Interventions in Patients Treated with prodisc® C Vivo at 2 Levels
概览
简要总结
The objective of the study is to evaluate the safety and post-operative performance profile of the prodisc® C Vivo after implantation in comparison to the relevant clinical literature.
详细描述
The primary objective of the study is to evaluate (estimate) the post-operative performance of prodisc® C Vivo overall, after implantation. Post-operative device performance will be estimated using Patient Reported Outcomes (PROs) and radiographic data derived from the patient's surgical charts and medical history.
The secondary objectives of this study are to assess:
- patients with no secondary surgical interventions (SSIs), i.e. revision, removal, re-operation, supplemental fixation at the index level(s)
- the rates of ADEs inclusive of intraoperative and post-operative complications
- Patient Reported Outcomes (PROs)
- Outcome self-assessment of Health Survey (SF 12 or 36 as available)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order for a patient's data to be included in this study, he/she has to meet the indications and not possess any of the specific or general contraindications listed in the Instructions For Use (IFU).
- •They must provide written informed consent with appropriate documentation noted in source documentation (prospective cohort only).
排除标准
- •There are no additional exclusion criteria.
研究组 & 干预措施
Retrospective chart review
Retrospective chart review of patients treated with prodisc® C Vivo at 2 contiguous levels.
干预措施: Prodisc C Vivo (Device)
Prospective follow-up
Prospective follow-up of patients treated with prodisc® C Vivo at 2 contiguous levels.
干预措施: Prodisc C Vivo (Device)
结局指标
主要结局
Evaluation of the Occurrence of Secondary Surgical Interventions in Patients Treated with prodisc® C Vivo at 2 Levels
时间窗: 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present
The primary objective of the study is to evaluate the post-operative performance of the prodisc® C Vivo after implantation by the occurrence of secondary surgical interventions in patients treated with prodisc® C Vivo at 2 levels. The State of the Art (SOTA) will be used as the comparison data collected in this study.
次要结局
- Assessment to demonstrate the continuous clinical and radiographic status of the prodisc C Vivo implants allowing characterization of performance of the device by nominal variables (percentages) based on ADEs, SSIs, PROs, and SF 12 data collection(10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present)