Operative Patient Positioning in Lumbar Fusion Surgery and Its Impact on Spinal Sagittal Balance and Surgeon Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- To assess if the specific intra-operative positioning affects post-operative sagittal alignment
研究概览
简要总结
This is a parallel, randomized controlled trial comparing two types of patient positioning and their effect on radiologic measures (pre-surgery visit, in the operating room prior to surgery, at the conclusion of surgery, and at 3 weeks after surgery at patients' postoperative visits) as well as surgeon satisfaction (prior to the end of the surgery) and patient outcomes using patient self reported scales (pre-surgery, post surgery at 3 weeks follow-up).
详细描述
The investigators are evaluating how patient positioning affects radiologic metrics as well as surgeon satisfaction (surgeon being blinded to positioning). Patients will be allocated to either a hyperlordotic or a standard positioning group by computer generated randomization. Surgeons will perform all of their standard techniques to promote lordosis with instrumentation. Adult patients, ages 18-65, undergoing lumbar surgical fusion will be asked to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients, aged between 18 and 65 years of age
- •Patients undergoing lumbar fusion for degenerative conditions
排除标准
- •Patients < 18 years of age or > 65 years of age
- •Patients who have a history of metastatic disease
- •Patients who currently have a pending workman's compensation claim
- •Patients who have had a previous spinal surgery
- •Patients who have or have had a spinal infection
- •Patients who have a spinal deformity, such as scoliosis
- •Women who are pregnant
- •Inpatients
结局指标
主要结局
To assess if the specific intra-operative positioning affects post-operative sagittal alignment
时间窗: Will be assessed during immediate post-operative period (day 1) as well as 3 weeks post-operatively
X-rays will be performed at patients' pre-surgery visit, in the operating room prior to surgery and at the conclusion of surgery, and at 3 weeks after surgery at patients' postoperative visit. The specifics of the pelvic parameters will be measured at these visits. Also, the patient will complete VAS, ODI (Davidson, 2002; Fairbank, 2000 ), and WHOQOL-BREF prior to surgery and at 3 weeks follow-up. We will collect data on any complications occurring in the perioperative period till 3 weeks after surgery
次要结局
- Surgeon satisfaction with operative patient positioning(During surgery (day 1))