Endoscopic Discectomy With Repair of Annulus Fibrosus Versus Discectomy Alone for Lumber Disc Herniation:A Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Postoperative therapeutic effect
研究概览
简要总结
The goal of this study is to explore the indications and application scope of spinal endoscopy combined with annulus fibrosus repair technology, with a focus on verifying the effectiveness of annulus fibrosus suture technology and evaluating its safety, so as to further support the promotion of annulus fibrosus repair technology in patients with lumbar disc herniation.
详细描述
- Background Lumbar Disc Herniation (LDH) is a significant clinical and public health issue, particularly due to its high incidence and impact on working-age populations. It is a leading cause of non-fatal health loss globally. While conservative management is first-line, surgery is indicated for refractory cases. Among surgical options, endoscopic discectomy has emerged as a superior minimally invasive technique, offering advantages like minimal trauma, rapid recovery, and preserved spinal stability compared to open surgery or fusion.
However, a key limitation of standard endoscopic discectomy is the residual defect in the annulus fibrosus (AF) after nucleus pulposus removal. This defect is a significant risk factor for postoperative recurrence, as residual disc material can re-herniate. Larger defects (≥6mm) are associated with significantly higher recurrence and reoperation rates. Annulus repair techniques, initially attempted in open surgery with limited success due to extensive tissue disruption, hold renewed promise in the minimally invasive endoscopic context. The recent development of dedicated endoscopic AF suture devices in China enables precise repair through the endoscope, potentially reducing recurrence and postoperative neural complications by restoring AF integrity, minimizing scar adhesion, and containing inflammatory mediators.
Preliminary clinical application of this AF suture technique in over 12,000 cases suggests it adds only minimal time (~8 minutes) to the procedure while offering significant potential benefits. This study aims to rigorously evaluate the safety and efficacy of endoscopic discectomy combined with AF repair versus discectomy alone through a prospective, multicenter, randomized controlled trial (RCT). 2. Study Objectives and Significance Primary Objectives:To evaluate the efficacy of AF repair in reducing the postoperative recurrence rate of LDH.To assess the safety of AF repair by comparing perioperative complications and early postoperative pain exacerbation between the suture and control groups.
Significance:This study will provide high-quality, multicenter RCT data to clarify the indications, technical nuances, clinical outcomes, and recurrence prevention effect of endoscopic AF suture. The findings will support the standardization and scientific application of this promising technology, offering valuable evidence for clinicians and patients in selecting optimal treatment strategies, particularly for young and active patients seeking rapid recovery and long-term durability. 3. Study Design and Methods Study Type: Prospective, multicenter, randomized controlled trial. Study Population:Participants: Patients aged 12-65 years diagnosed with symptomatic LDH from multiple participating centers.
Inclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 12 years old to 65 years old, gender not limited;
- •Diagnosed with Lumbar disc herniation;
- •Preoperative intervertebral disc MRI Pfirrmann grade I - II;
- •Conservative treatment is ineffective, and the symptoms significantly affect life;
- •Be able to cooperate with long-term follow-up and sign the informed consent form.
排除标准
- •Accompanied by lumbar spondylolisthesis, lumbar instability and other lumbar diseases, etc.
- •Previous history of lumbar spine surgery;
- •Those who have other major physical diseases and are unable to tolerate surgery;
- •Diseases such as malnutrition, abnormal bone metabolism, and autoimmune diseases that may affect the postoperative development process;
- •Unable to accept regular follow-up visitors
研究组 & 干预措施
Annulus fibrosus repair
Annulus fibrosus repair, Suture the incision of the annulus fibrosus
干预措施: Repair of the annulus fibrosus (Procedure)
Non-annulus fibrosus repair
Non-annulus fibrosus repair, Do not suture the incision of the annulus fibrosus
结局指标
主要结局
Postoperative therapeutic effect
时间窗: Within one year
The change of the quality of life of postoperative patients was evaluated by using the VAS(Visual Analog Score), Zero to ten points indicates the degree of pain from mild to severe
Recurrence rate
时间窗: Within one year
The proportion of lumbar intervertebral disc protrusion recurring at the surgical segment within a certain period after surgery, including short-term recurrence and long-term recurrence.
次要结局
- Nerve injury(Within one year)
研究者
maxuexiao
Endoscopic Discectomy with Repair of Annulus Fibrosus versus Discectomy Alone for Lumber Disc Herniation:A prospective Multicenter Randomized Controlled Trial
The Affiliated Hospital of Qingdao University