The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- fusion rate at postoperative 1 year
研究概览
简要总结
The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine function and quality of life after spinal fusion.However, as the review article presented, it lacks high-quality evidence to investigate the role of vitamin D supplements in spinal fusion. Therefore, this randomized controlled trial aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients receiving elective lumbar spinal fusion.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years
- •Indicated of elective spine fusion surgery for spinal stenosis or degenerative spondylolisthesis at the study hospital from January 2016 to December 2017.
排除标准
- •Spinal instability due to trauma, infection, or malignancy
- •History of previous spine surgery
- •Hemodialysis
- •Long-term steroid use
- •History of medical treatments for osteoporosis
- •Postoperative follow-up for less than 12 months
- •Newly-onset compression fracture after study procedure
结局指标
主要结局
fusion rate at postoperative 1 year
时间窗: postoperative 1 year
Fusion status were assessed by radiography and computed tomography of the lumbar spine. Fusion was defined as the presence of bridging callus without radiolucent line, spinal range of motion between two fused vertebrae less than 5 degrees, and no implant loosening or failure on lumbar spine radiography.
次要结局
- spine function at postoperative 6 months(postoperative 6 months)
- pain at postoperative 3 months(postoperative 3 months)
- pain at postoperative 6 months(postoperative 6 months)
- time to fusion(from postoperative day 1 to postoperative 1 year)
- spine function at postoperative 3 months(postoperative 3 months)
研究者
Pei-Yuan Lee, MD
Honorary President
Show Chwan Memorial Hospital