An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 5
- 主要终点
- Rates of complications attributable to the use of the Modulus ALIF System
研究概览
简要总结
The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
详细描述
Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site who meet eligibility requirements will be considered for participation in the study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.
The complication profile and overall performance of the Modulus ALIF System will be assessed using the following:
- Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and
- Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and
- Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
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
- •Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
- •Male or female patients who are ≥18 years of age at the time of surgery
- •Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome
- •Treated with ALIF procedure with the Modulus ALIF System at:
- •One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or
- •Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as >10º coronal curve) or sagittal deformity
- •Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:
- •1-2 levels treated for DDD, and
- •3 or 4 interfixated screws placed, and
- •Implant lordosis is ≤20°
排除标准
- •Patient was a prisoner at the time of Modulus ALIF treatment
- •Patient was participating in another clinical study during treatment that would confound study data
结局指标
主要结局
Rates of complications attributable to the use of the Modulus ALIF System
时间窗: 12 months
Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative
时间窗: 12 months
次要结局
- Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available(12 months)