Multi-Center Randomized Controlled Clinical Study on the Application of a Novel Expandable Posterior Bone Grafting OLIF Cage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 340
- 主要终点
- Postoperative cage subsidence
研究概览
简要总结
This clinical trial aims to evaluate the safety and effectiveness of a novel expandable OLIF (Oblique Lateral Interbody Fusion) cage with posterior bone grafting in patients with lumbar degenerative diseases. OLIF is a minimally invasive spinal surgery technique that restores intervertebral height and relieves nerve compression by placing a cage into the disc space.
The new device allows surgeons to adjust the height of the cage during surgery and deliver bone grafts through a special channel after expansion. This study compares the outcomes of patients receiving the new cage versus those treated with a conventional OLIF cage.
The trial will assess pain relief, functional improvement, spinal stability, fusion success, and potential complications. Radiological images and patient-reported scores (like VAS and ODI) will be collected over 12 months. The study includes patients aged 40 to 80 with single-level lumbar spine disease who have not improved after at least 6 months of conservative treatment.
This study will help determine whether the new expandable cage offers clinical advantages and better long-term outcomes for patients undergoing OLIF surgery.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Age between 40 and 80 years (inclusive)
- •2: Clinically diagnosed with lumbar spondylolisthesis or lumbar spinal stenosis
- •3: Confirmed single-level lumbar degenerative disease
- •4: Affected level located at L2/3, L3/4, or L4/5
- •5: Failure of conservative treatment for at least 6 months
排除标准
- •1: Patients requiring direct decompression of the spinal canal
- •2: History of prior lumbar or retroperitoneal surgery
- •3: Abnormal anatomy between the iliac vascular sheath and the psoas major muscle
- •4: Presence of active infection or other significant systemic diseases
- •5: Inability to complete surgical treatment or comply with follow-up due to various limitations
结局指标
主要结局
Postoperative cage subsidence
时间窗: From enrollment to the 12th month after operation
Radiological follow-up will be conducted immediately after surgery, and at 6, 12 months postoperatively using X-ray and/or CT imaging. Cage subsidence is defined as: ≥2 mm of cage penetration into the adjacent vertebral endplate compared to immediate postoperative imaging; Visible collapse of the cage-endplate interface; ≥10% reduction in intervertebral height compared to initial postoperative height. All radiographic assessments will be performed independently by two spine surgeons or radiologists blinded to group allocation. In case of discrepancy, a third reviewer will adjudicat
ntraoperative cartilage endplate injury
时间窗: From enrollment to the 12th month after operation
Endplate injury will be assessed intraoperatively by the operating surgeon through direct visual inspection and intraoperative fluoroscopy. Injury is defined as any of the following: Visible collapse, fracture, or tearing of the cartilaginous endplate during cage insertion; Evidence of asymmetric or excessive endplate compression on fluoroscopy; Explicit documentation of "endplate injury" or "endplate violation" in the operative record. Injury will be recorded in binary form (Yes/No). When necessary, postoperative CT scans may be used to confirm suspected endplate damage.
次要结局
- Cobb angle of lumbar deformity surface(From enrollment to the 12th month after operation)
- Clinical efficacy index of patients: ODI(From enrollment to the 12th month after operation)
- Intervertebral Height(From enrollment to the 12th month after operation)
- Clinical efficacy index of patients: VAS(From enrollment to the 12th month after operation)
- Cobb angle of lumbar coronal plane(From enrollment to the 12th month after operation)