Clinical and Radiological Outcomes of Oblique Lateral Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Fusion rate
研究概览
简要总结
This study is undertaken to evaluate the outcomes of Oblique Lateral Lumbar Interbody Fusion (OLLIF). Specifically, the study seeks to measure outcomes on radiological imaging, outcomes reported by the patients on standardized questionnaires, and complication rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis, confirmed by imaging, of one of the following conditions: severe degenerative disc disease, spondylolisthesis, spinal stenosis, disc herniation
- •Completion of a full course of conservative therapy. Conservative therapy may include physical therapy, therapeutic injections, bracing and behavioral modification.
排除标准
- •bony obstruction of the approach
- •significant spinal canal stenosis
- •large facet hypertrophy
- •grade II listhesis
- •scoliosis with Cobb angle > 10º
- •Patients who underwent procedures that were converted to open fusions
结局指标
主要结局
Fusion rate
时间窗: One year after surgery
The rate of bony fusion as determined by independent radiologists on post-operative CT scans. Radiologists will determine whether each level that was operated on was fused, or not fused.
Rate of Nerve Root Irritation
时间窗: One year after surgery
Nerve Root Irritation is defined as lower extremity paresthesias or dysesthesias corresponding to dermatome of the level of surgery or weakness of 4/5 or above on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.
Patient reported disability on the Oswestry Disability Index
时间窗: One year after surgery
The Oswestry Disability Index is a commonly used tool to assess disability due to low back pain. The Oswestry is assessed on a standardized questionnaire and the scale ranges from 0% to 100% disability. A lower score is considered less disability.
Rate of Neuropraxia
时间窗: One year after surgery
Neuropraxia is defined as lower extremity weakness of 3/5 or below on a standard 5 point strength scale as assessed by the surgeon at one year follow-up. The scale ranges from 5 (full strength) to 0 (no muscle tone). The deficit must have newly appeared just after surgery to be considered a result of the surgery.
次要结局
- Hospital stay(Immediately after surgery)
- Blood Loss(During surgery)
- Fluoroscopy Time(During surgery.)
- Infection Rate(Immediately after surgery)
- Patient reported pain on a 10-point pain scale(One year after surgery)
- Rate of screw fracture(One year after surgery)
- Surgery Time(During surgery)
- Bleeding Rate(During surgery and immediately after surgery)