REESE - Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- UIV Screw Loosening Rate
研究概览
简要总结
The REESE study is looking at information from past spine surgeries to learn how often screws placed at the top of a spinal fusion become loose over time. Researchers will review existing medical records and X-rays from adults who have already had thoracolumbar spinal fusion surgery. The study will also look at factors that may increase the risk of screw loosening and whether it leads to additional complications or surgeries. No new procedures, treatments, or patient visits are required because the study uses information that has already been collected during routine medical care.
详细描述
The REESE (Retrospective Evaluation of Upper Instrumented Vertebrae Screw Loosening Following Spine Surgery) study is a multicenter, retrospective chart review that aims to determine the rate of screw loosening at the upper instrumented vertebra (UIV) following thoracolumbar spinal fusion surgery and identify associated risk factors. Up to 400 patients from up to 10 U.S. sites will be included. Eligible patients must be adults who underwent thoracolumbar fusion with bilateral UIV screws and have at least 12 months of postoperative imaging follow-up.
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
- •≥ 18 years of age at the time surgery
- •Underwent thoracolumbar spinal fusion with bilateral screws at the UIV
- •Construct <4 levels ending at the sacrum may be treated with or without pelvic fixation
- •Constructs ≥4 levels ending at the sacrum must include pelvic fixation
- •Constructs not ending at the sacrum may be included
- •Patient must have a minimum of 12-month follow-up including imaging (AP and lateral x-rays)
排除标准
- •Treated for high grade (grade III, IV, or V) spondylolisthesis
- •Diagnosed with primary or metastatic tumor involving the spine, history of spinal malignancy, or active cancer at the time of surgery
研究组 & 干预措施
Thoracolumbar Fusion Cohort
Adults who underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV) within the previous 5 years and had at least 12 months of postoperative follow-up imaging. Patients will be identified retrospectively from participating sites and evaluated for the incidence of UIV screw loosening and associated clinical and radiographic risk factors.
结局指标
主要结局
UIV Screw Loosening Rate
时间窗: 12-month follow-up
Rate of UIV screw loosening as assessed on x-rays
次要结局
- Adverse Events Associated with UIV Screws(12-month follow-up)
- Rate of Subsequent Surgical Intervention Involving the UIV(12-month follow-up)
- Rate of UIV Screw Removal(12-month follow-up)
研究者
Bryan Ladd
Principle Investigator
Ohio State University