Modified Mini-Open TLIF Versus Traditional Open TLIF for Lumbar Spinal Stenosis : A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
This clinical study aims to find out if a modified mini-open spine surgery (modified mini-open transforaminal lumbar interbody fusion，mMO-TLIF) is as good as, or better than, the traditional open surgery (traditional transforaminal lumbar interbody fusion，traditional TLIF) for treating low back pain, leg pain, and walking difficulties caused by lumbar spinal stenosis with instability. The study will also look at the safety of both surgeries.
It is designed to answer these main questions:
Is the mMO-TLIF surgery as good as the traditional TLIF surgery at improving patients' lower back function and quality of life? Does the mMO-TLIF surgery reduce blood loss during the operation and shorten hospital stays and recovery time? What medical problems (like infections or nerve injuries) might patients experience after having the mMO-TLIF surgery? Researchers will compare the results of the mMO-TLIF surgery group with the traditional TLIF surgery group to see which one works better.
Participants will:
Be randomly assigned to receive either the mMO-TLIF minimally invasive surgery or the traditional TLIF open surgery.
Come back to the hospital for check-ups before surgery, and then at 1 month, 3 months, 12 months and 24 months after surgery.
During these check-ups, they will have physical exams, fill out questionnaires about their symptoms, dysfunction and quality of life, and get X-rays or CT scans to see how their bones are healing.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years.
- •Presence of unilateral neurogenic claudication or radicular pain in the lower limbs, with failure to respond to at least 3 months of conservative treatment.
- •Presence of bilateral neurogenic claudication or radicular pain in the lower limbs, but with complete resolution of neurological symptoms in at least one lower limb during recumbency and an unremarkable physical examination, alongside failure to respond to at least 3 months of conservative treatment.
- •Radiologically confirmed single- or two-level lumbar spinal stenosis on MRI, with evidence of instability specifically at the stenotic level(s) on standing lateral radiographs.
- •The mMO-TLIF or TLIF surgical procedure is performed by the same lead surgeon at each participating investigational site.
- •Subjects voluntarily participate and provide written informed consent.
排除标准
- •Presence of bilateral radicular pain in the lower limbs that does not completely resolve at rest.
- •History of previous lumbar spine trauma or surgery.
- •Presence of spinal infection, tuberculosis, or tumor.
- •Contraindications to surgery, such as severe systemic medical diseases, coagulation disorders, severe active infectious diseases, or osteoporosis.
- •Significant intervertebral space collapse, presence of bony ankylosis, etc.
- •Incomplete data.
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: preoperatively and 1/3/12/24 months postoperatively
Oswestry Disability Index (ODI), a 10-item questionnaire scored from 0 (no disability) to 100 (maximum disability), with higher scores indicating worse disability.
次要结局
- Pain VAS scores(preoperatively and 1/3/12/24 months postoperatively)
- Intraoperative Blood Loss(Immediately upon surgery conclusion)
- Time to Ambulation(Time from surgery to first ambulation, assessed during postoperative hospital stay up to 30 days)
- Length of Hospital Stay(Length of hospital stay from surgery to discharge, assessed up to 30 days.)
- Incidence of complications(From surgery start until 24 months postoperatively.)
- Radiographic fusion rate(12 months postoperative)
- Zurich Claudication Questionnaire (ZCQ) score(Preoperative and 1/3/12 months postoperative)
- Brock Quality of Life Five Dimensions (EQ-5D-3L) questionnaire score(1/24 month postoperatively)
- Operative Time(Immediately upon surgery conclusion)
- Transfusion Rate(From surgery start until hospital discharge, assessed up to 30 days.)