Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) scores
研究概览
简要总结
TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Patient is willing to be available for each examination scheduled over the study duration.
- •Lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation.
- •Patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block.
- •Has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other).
排除标准
- •Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
- •Has presence of active malignancy
- •Has a history of severe allergy
- •Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
- •Pregnant, or may become pregnant within follow-up period of study
- •Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
- •Spondylolisthesis at the target level
- •Has undergone previous lumbar surgery
- •Has severe osteoporosis (T-score ≤ -3.5)
- •BMI > 35kg/m2
- •Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
- •Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)
结局指标
主要结局
Visual Analogue Scale (VAS) scores
时间窗: 2 years postoperatively
次要结局
- Operative duration(1 week postoperatively)
- Estimated blood loss(1 week postoperatively)
- Foraminal height(2 years postoperatively)
- Fusion rate(2 years postoperatively)
- Adverse events related to procedure(2 years postoperatively)
- Spinal angles(2 years postoperatively)
- Oswestry Disability Index (ODI)(2 years postoperatively)
- Cost of treatment(2 years postoperatively)
- Length of hospital stay(1 week after discharge)
- Intervertebral space height(2 years postoperatively)
研究者
Xiaofei Cheng
Principal Investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University