Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Prospective Controlled Randomized Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels/Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.
研究概览
简要总结
This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.
详细描述
Currently, there are two different surgical methods used in the treatment of these problems. One method includes an all open posterior spinal fusion (large incision with opening of the muscles); this is also known as a traditional technique. The second method involves an open surgery for the portion of the spine requiring a fusion except the very top area, where minimally invasive technique (smaller incision and without opening of the muscles) is used.
One possible side effect of either method for surgical repair is a condition called proximal junctional kyphosis (PJK). PJK occurs in the form of fracture at the top vertebra involved in the surgery or as a loss of correction of spinal alignment achieved, through gradual bending forward of the spine over time. In this study we want to compare the rate of PJK between two groups of patients undergoing long posterior spinal instrumentation fusion.
People undergoing long posterior spinal instrumented fusion may join.
About 68 people will join.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Individuals presenting for surgical correction of scoliosis and/or kyphosis of the thoracolumbar spine are the primary target for enrollment.
- •Men and women ages 18 years or older will be eligible for participation in the current study.
- •In addition, individuals must be able to provide informed consent (Mini-Mental State Examination score of at least 18/30).
排除标准
- 未提供
研究组 & 干预措施
Traditional technique
All level open instrumented posterior spinal fusions
干预措施: Traditional technique (Procedure)
Minimally invasive technique
Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.
干预措施: Minimally invasive technique (Procedure)
结局指标
主要结局
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.
时间窗: 12 months
rate of proximal junctional fracture or instrumentation failure
次要结局
- To evaluate complication rate between the two groups.(3 months)
- To compare the total operative time between the two groups of surgical patients (as stratified above).(12 months)
- To compare the length of hospital stay between the two groups of surgical patients (as stratified above).(12 months)
- To compare the total recovery time between the two groups of surgical patients (as stratified above).(12 months)
- To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).(12 months)
- To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).(12 months)