Transforaminal/Posterior Lumbar Interbody Fusion With the FlareHawk® Expandable Interbody Fusion Device: A Retrospective Chart Review Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 3
- 主要终点
- Radiographic Arthrodesis
研究概览
简要总结
This is a retrospective clinical study (chart review) of patients who have previously undergone Transforaminal Lumbar Interbody Fusion or Posterior Lumbar Interbody Fusion surgery with the FlareHawk expandable interbody fusion cage at one or two contiguous levels.
详细描述
The purpose of this study is to evaluate the clinical outcomes of patients who have undergone a Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedure with a FlareHawk expandable interbody fusion cage(s) to assess the device's performance and safety when used in accordance with its intended use. The primary hypothesis is that study subjects who received the FlareHawk expandable cage(s) through a TLIF or PLIF procedure experienced fusion by 12 months (+/- 3 mo) follow-up, with improvements in clinical outcomes related to pain and/or disability compared to pre-operative scores. Further, the subjects are hypothesized to have not experienced any unforeseen device- or procedure-related adverse events.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be a part of this study, the subject must:
- •Have been at least 18 years of age and skeletally mature at the time of surgery
- •Have had clinical and radiological evidence of degenerative disc disease of the lumbar spine
- •Have been treated with PLIF or TLIF surgery using the FlareHawk expandable interbody cage(s) at 1 or 2 contiguous levels from L2 to S1
- •Have been treated using the FlareHawk expandable interbody fusion cage, according to the approved labeling, between December 1, 2017, and May 31, 2018
排除标准
- •Subjects must not meet any of the following exclusion criteria to be included in the study:
- •Have a history of fusion surgery at the study level(s) prior to treatment with the FlareHawk device(s)
- •Have had spondylolisthesis unable to be reduced to grade 1 as part of the surgical procedure
- •Have had surgery with the FlareHawk device(s) at more than 2 levels
- •Have had surgery with the FlareHawk device(s) at levels outside the range of L2 to S1
- •Have been treated with any bone grafting material other than autogenous or allogenic bone graft in the FlareHawk device(s) and surrounding disc space
- •Have any contraindications listed in the approved labeling
结局指标
主要结局
Radiographic Arthrodesis
时间窗: 12 months +/- 3 months
Proportion of participants with radiographic arthrodesis at 12 months +/- 3 months as determined using plain radiographic images with assessment based on the Bridwell-Lenke grading system \[Bridwell and Lenke et al, 1995\].
次要结局
- Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up(From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo))
- Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up(From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo))
- Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up(From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo))