Efficacy and Safety of Endo-Surgi Plus Endoscopy, UBE Endoscopy, and Microdiscectomy Decompression Techniques for the Treatment of Lumbar Spinal Stenosis: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- The Oswestry Disability Index scores
研究概览
简要总结
The purpose of this study is to conduct a multicenter comparison of the clinical efficacy of Endo-Surgi Plus endoscopic technique, UBE endoscopic technique, and microdiscectomy technique in the treatment of lumbar spinal stenosis, and to compare the differences in the incidence of complications, surgical trauma, and other aspects among the three surgical techniques for the treatment of lumbar spinal stenosis.
Each group of patients received either Endo-Surgi Plus endoscopy, UBE, or microdiscectomy decompression through the Quadrant channel. All patients were routinely administered low-dose hormones, dehydrating agents, and neurotrophic drugs postoperatively. Patients were required to strictly avoid strenuous activities and heavy lifting in the lumbar region for three months after surgery. Upon discharge, patients were provided with the same lumbar and back muscle rehabilitation exercises and other postoperative recovery-related discharge education. Each group of patients was followed up for at least one year, with follow-up including outpatient visits, physical examinations, questionnaire scoring, and necessary auxiliary examinations.
Both two endoscopic surgeries, as surgical techniques that have been used in clinical practice for many years, have their efficacy confirmed by various studies. The investigator proposes that these two techniques may have similar clinical efficacy to microdiscectomy, while also offering the advantage of being less invasive. The aim of this study is to validate these assumptions. At the same time, there may be some differences between the two endoscopic surgeries that require further verification.
详细描述
The lumbar spine is the part of the spine that bears the most weight, consisting of five vertebrae. Each vertebra is connected by an intervertebral disc, and together they form a barrier to protect the spinal cord nerves within the spinal canal. Lumbar spinal stenosis refers to the reduction of space within the lumbar spinal canal, which compresses the spinal cord or nerve roots, leading to a series of symptoms. Depending on the cause, lumbar spinal stenosis is mainly divided into congenital lumbar spinal stenosis, which is due to abnormal development of the spinal canal, and acquired lumbar spinal stenosis, which is caused by degenerative changes such as lumbar disc degeneration and joint process hyperplasia. Lumbar spinal stenosis is a common cause of low back and leg pain, with a reported incidence rate as high as 11% in the general population and 19.4% in those over 60 years old, with a trend of increasing with age. With the aging of the population, the incidence of lumbar spinal stenosis is also on the rise.
The treatment of lumbar spinal stenosis mainly includes conservative treatment and surgical treatment. For patients whose symptoms severely affect their lives and do not respond well to conservative treatment, surgery should be performed as soon as possible to relieve nerve compression. The main goal of surgical treatment for lumbar spinal stenosis is to relieve nerve compression, stabilize the spine, and restore the normal volume of the spinal canal. Although traditional posterior lumbar decompression surgery can achieve definite decompression effects, it has issues such as severe destruction of posterior column structures and large surgical trauma. Minimally invasive techniques are a hot topic in various clinical fields, and microdiscectomy (MD) through a minimally invasive channel is a mature minimally invasive technique for treating lumbar spinal stenosis. As early as 1999, prospective randomized controlled studies confirmed that it has the same excellent clinical efficacy as open surgery but with less surgical trauma. It has now become a classic surgical method for treating lumbar spinal stenosis, with related articles published in the top spinal clinical journal JBJS.
In recent years, with the development of new equipment, endoscopic techniques have been gradually applied to the treatment of lumbar spinal stenosis. Unilateral biportal endoscopic discectomy (UBE) has the characteristics of convenient operation and flexibility because its endoscopic channel and working channel are separate and can use traditional open instruments. It can achieve good decompression effects and has been widely used in various medical centers. Percutaneous endoscopic lumbar discectomy (PELD), as a new generation of endoscopic technique, has less surgical trauma and shorter operation time. It has also been successfully applied to the clinical treatment of lumbar spinal stenosis and achieved good results. However, due to the limitations of the single-endoscopic channel field of view, its learning curve is steep, the surgical difficulty is high, and it is difficult to achieve complete decompression for bilateral spinal stenosis or dorsal nerve root compression. The efficiency of dealing with bony stenosis structures during surgery is low, leading to longer operation time and increased risk of nerve root and dural sac injury. Many clinical studies have compared the advantages and disadvantages of endoscopic techniques with traditional minimally invasive techniques and different endoscopic techniques, concluding that various endoscopic techniques can achieve surgical efficacy similar to traditional techniques with the advantages of less surgical trauma and faster postoperative recovery. Guilherme et al. believe that PELD has similar clinical efficacy to MD, but MD is superior for complex foraminal stenosis. In addition, a review by Ohyuk et al. suggests that UBE has better clinical efficacy and a lower complication rate compared to MD or PELD. However, most of these studies are small-scale, single-center, and retrospective, and the conclusions lack high-quality evidence support.
In recent years, single-channel decompression techniques under endoscopy have developed rapidly, especially large-channel endoscopes and related tools, which have significantly improved work efficiency and surgical safety. Many hospitals and medical research centers have introduced the Endo-Surgi Plus working channel, which has a larger working tube than traditional endoscopes, making it easier to treat certain types of lumbar disc herniation and lumbar spinal stenosis, further optimizing spinal endoscopic surgery techniques for lumbar spinal stenosis.
With the development of surgical instruments and approaches, these three minimally invasive spinal canal decompression techniques can effectively relieve pain symptoms in patients with various types of lumbar spinal stenosis. Compared with traditional open surgery, these techniques have reduced operation time, intraoperative blood loss, and postoperative pain. However, there are slight differences in the degree of trauma and ease of operation among these three techniques. Currently, there is still a lack of prospective validation of the clinical efficacy of these surgical techniques internationally, and the advantages and disadvantages of different endoscopic surgeries compared to traditional fenestration surgery.The purpose of this study is to conduct a multicenter comparison of the clinical efficacy of Endo-Surgi Plus endoscopic technique, UBE endoscopic technique, and microdiscectomy technique in the treatment of lumbar spinal stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, 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
- •Diagnosed with single-segment lumbar spinal stenosis through CT and MRI imaging combined with clinical symptoms;
- •Symptoms in the lumbar region and lower extremities corresponding to the imaging findings;
- •Patients who have not responded to three months of conservative treatment;
- •Informed consent from family members regarding the surgical procedure and associated risks.
排除标准
- •Patients with multi-segment lumbar disc herniation, malignant spinal tumors, spinal deformities, and other diseases.
- •Patients with comorbidities such as cardiovascular diseases, cerebrovascular diseases, or those with mental abnormalities, communication difficulties, or other issues that may affect clinical evaluation.
- •Patients with a history of previous lumbar surgery.
研究组 & 干预措施
Unilateral biportal endoscopic group
干预措施: Unilateral biportal endoscopic surgery (Procedure)
Microdiscectomy group
干预措施: Microdiscectomy (Procedure)
Endo-Surgi Plus endoscopic group
干预措施: Endo-Surgi Plus endoscopic surgery (Procedure)
结局指标
主要结局
The Oswestry Disability Index scores
时间窗: 1 year postoperatively
The maximum score is 100 points, and the minimum score is 0 points. The higher the score, the more severe the functional impairment.
次要结局
- The Oswestry Disability Index scores(preoperatively, 1 day, 3 months, and 6 months postoperatively)
- Visual Analogue Score for lower limb pain/lumbar back pain(preoperatively, 1 day, 3 months, 6 months, and 1 year postoperatively)
- The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36 score)(preoperatively, 1 day, 3 months, 6 months, and 1 year postoperatively)
- Dural sac cross-sectional area calculated from lumbar MRI(preoperatively and at 1 year postoperatively)
- Creatine kinase-MB (CK-MB)(preoperative and immediate postoperative)
- Surgery time(Immediate postoperatively)
- Intraoperative blood loss(Immediate postoperatively)
- Surgical incision length(Immediate postoperatively)
- Postoperative hospital stay(Immediate postoperatively)
- Perioperative complication rate(Immediate postoperatively)
