Multicenter, Retrospective, Observational Clinical Study to Evaluate Clinical Outcome Measures and Safety Profiles for Patients With SDDD Treated With STALIF® C, or M, Ti or FLX Implants for 1 and 2 Levels.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Oswestry Disability Index (ODI) Questionnaire
研究概览
简要总结
This is a Retrospective, Observational Multi-Center study, utilizing patients diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or symptomatic degenerative disc disease and treated with STALIF® C, or M, Ti and/or FLX implants at one or two levels.
详细描述
The study is intended to codify the performance of the STALIF family of products. Its design is to provide retrospective data derived from the patient's medical and surgical chart and prospectively assess the treating surgeon and patient on their level of satisfaction post-operative up to present.
All subjects who sign an informed consent will be included in the prospective data collection via chart review at the individual investigational sites. The prospective data will come from subjects who complete the designated patient assessments as well as the treating surgeon. The data collection period will include surgeries performed between 2014 to present.
The analysis will support the safety profile of the product family and allow for comparison to the available literature as well as between device types (Ti versus FLX). Furthermore, data from this study will support post-market surveillance requirements for the STALIF family of products.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or degenerative disc disease of the cervical or lumbar spine at time of surgery.
- •2 levels, between:
- •C: C2-T1 (neck)
- •M: L2-S1 (low back)
- •Skeletally mature at the time of surgery with clinical and radiological evidence of degenerative disc disease of the cervical or lumbar spine.
排除标准
- •Subject who had surgery with the STALIF devices at more than 2-levels.
- •In the Investigator's opinion, the subject diagnosed with a disease or condition, which precludes the possibility of healing at the time of surgery
结局指标
主要结局
Oswestry Disability Index (ODI) Questionnaire
时间窗: Change from baseline at 24 months
Assessing low back disability. Questionnaire consists of 10 sections with 6 possible choices in each section. Patient to choose 1 answer that best describes his/her ability to manage everyday activities. The questions weighted and summarized providing physical and mental health scores (PCS and MCS) ranging from 0 to 100. High scores indicating worse outcome and lower scores indicating better outcomes.
Neck Disability Index (NDI)
时间窗: Change from baseline at 24 months
Assessing cervical neck disability questionnaire. Questionnaire consists of 10 sections with 6 possible choices in each section. Patient to choose 1 answer that best describes his/her ability to manage everyday life activities. The questions weighted and summarized providing physical and mental health scores (PCS and MCS) and range from 0 to 100. High scores indicating worse outcome and lower scores indicating better outcomes.
次要结局
- Adverse Events(Day of surgery to 12 months)
- Surgeon Self Satisfaction Survey(Post-op at 24 months)
- Patient Self Satisfaction Survey(Post-op at 24 months)
- Quality of Lift Questionnaire (SF-12) Prospective Arm of Study(Post-op at 24 months.)
- Surgical Interventions(Post-op Day 1 of surgery to 6 months)