A Single-center Review of the Performance of Induce Biologics NMP™ in Patients Who Have Undergone Interbody Fusion for Degenerative Disease of the Lumbar Spine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Radiographic fusion rate
研究概览
简要总结
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
详细描述
The study involves a retrospective review of patients' medical records and prospective collection of CT scans, X-rays, and patient centered outcome questionnaires.
The study population will include up to 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study.
There will be a single Prospective Visit in this study. This visit will be scheduled at the 12-month (± 2 mo) post-surgery time point.
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
- 否
入选标准
- •Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
- •Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.
- •Be at least 18 years of age.
- •Have current contact information.
- •Be willing and able to provide written Informed Consent for the prospective part of study participation.
- •Be willing and able to undergo a CT-scan and X-rays.
- •Be willing and able to complete patient centered outcome questionnaires.
排除标准
- •Currently imprisoned.
- •Currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin.
- •X-rays or CT-scan are contraindicated.
- •Any previous lumbar fusion or arthroplasty surgery at the index level(s)
研究组 & 干预措施
NMP
Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
Have been treated with NMP™ during a lumbar spinal fusion procedure.
干预措施: Natural Matrix Protein (NMP) (Biological)
结局指标
主要结局
Radiographic fusion rate
时间窗: 12-months post-surgery
CT scans will be graded from 0 (no boney ingrowth) to 3 (complete bridging) and A (no evidence of supplemental fixation failure) or B (evidence of supplemental fixation failure). Fusion will be defined as a CT grade of 3A with less than 3 degrees of motion at the index level on flexion and extension x-rays.
次要结局
- Change in disability score assessed by the 12-Item Short Form Survey version 2(Baseline to 12 months post-operative)
- Change in disability score assessed by Oswestry Disability Index(Baseline to 12 months post-operative)
- Change in pain score - for the Back(Baseline to 12 months post-operative)
- Adverse Events (AE) related to NMP(Baseline to 12 months post-operative)
- Change in neurologic status(Baseline to 12 months post-operative)
- Revisions/reoperations(Baseline to 12 months post-operative)
- Change in pain score - for the Left Leg(Baseline to 12 months post-operative)
- Change in pain score - for the Right Leg(Baseline to 12 months post-operative)
- Duration of hospitalization(time of surgery to time of discharge, assessed up to 12 months)