RenewDisc Trial: A Prospective Observational Study Comparing Endoscopic Discectomy and Autologous Mesenchymal Stem Cell Therapy in Patients With Discogenic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
he RenewDisc Trial is a prospective observational clinical study evaluating outcomes in patients with confirmed discogenic low back pain who undergo standard clinical care using endoscopic spine procedures. The study observes and compares clinical, functional, and imaging outcomes following endoscopic discectomy, endoscopic discectomy combined with autologous mesenchymal stem cell therapy, or standalone endoscopic application of autologous mesenchymal stem cells.
Participants are treated according to routine clinical decision-making, and no interventions are assigned by the study protocol. Data are collected prospectively at predefined follow-up intervals to assess pain intensity, functional disability, quality of life, and structural changes on magnetic resonance imaging.
详细描述
Discogenic low back pain is a frequent cause of chronic disability and remains challenging to treat when conservative management fails. Endoscopic spine techniques have emerged as minimally invasive options that allow targeted treatment of disc pathology with reduced tissue trauma. In parallel, regenerative approaches using autologous mesenchymal stem cells have gained interest due to their potential biological effects on disc degeneration.
The RenewDisc Trial is designed as a prospective observational cohort study to systematically collect and analyze real-world clinical data from patients with confirmed discogenic low back pain who undergo endoscopic spine procedures as part of routine clinical care. The study does not assign or randomize treatments. All therapeutic decisions, including the choice of procedure, are made independently by the treating physician based on standard clinical indications and patient preference.
Patients included in the study undergo one of the following standard clinical approaches: endoscopic discectomy, endoscopic discectomy combined with autologous mesenchymal stem cell application, or standalone endoscopic application of autologous mesenchymal stem cells. These approaches represent established clinical practices at participating centers. The study observes outcomes associated with each approach without altering standard care pathways.
Clinical outcomes are assessed prospectively using validated patient-reported outcome measures, including pain intensity scales, functional disability, and health-related quality of life. Imaging follow-up with magnetic resonance imaging is performed at predefined intervals to evaluate structural changes of the intervertebral disc. In patients undergoing bone marrow aspiration as part of standard care, cellular characteristics of the aspirate are analyzed descriptively.
Data are collected at baseline and during scheduled follow-up visits and are recorded using anonymized, randomly generated participant identifiers. The study aims to provide comparative real-world evidence on clinical, functional, and imaging outcomes associated with contemporary endoscopic and regenerative spine treatment strategies for discogenic low back pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Clinical diagnosis of discogenic low back pain
- •Positive provocative discography of the target intervertebral disc
- •Negative medial branch block
- •Preserved lumbar intervertebral disc height greater than 50%
- •Pfirrmann grade I-II on lumbar spine MRI
- •Back pain with or without radicular pain
- •Back pain representing at least 30% of the patient's total reported pain
排除标准
- •Lumbar intervertebral disc height reduction greater than 50%
- •Presence of Schmorl's nodes in adjacent vertebrae
- •Acute or chronic infection
- •Presence of hematological disorders
- •Back pain representing less than 30% of the patient's total reported pain
- •Contraindication to endoscopic spine procedures
- •Refusal or inability to provide written informed consent
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: From baseline to 24 months after the procedure
Outcome Measure Description: The ODI is a validated 10-item, self-administered questionnaire assessing back-specific functional disability. Total score is converted to a 0-100 scale; higher scores indicate greater disability.
Change From Baseline in Numerical Rating Scale (NRS) for Back Pain
时间窗: From baseline to 24 months after the procedure
The Numerical Rating Scale (NRS) is a patient-reported measure of pain intensity ranging from 0 (no pain) to 10 (worst imaginable pain). Patients rate their average back pain intensity at each assessment time point.
Change From Baseline in Visual Analog Scale (VAS) for Leg Pain
时间窗: From baseline to 24 months after the procedure
The Visual Analog Scale (VAS) is a 10-cm continuous scale used to assess pain intensity, anchored by "no pain" (0) and "worst imaginable pain" (10).
Magnetic Resonance Imaging (MRI) Assessment of Intervertebral Disc Morphology
时间窗: At 6, 12, and 24 months after the procedure
MRI evaluation of structural disc changes, including disc height, signal intensity, and degenerative features, assessed at predefined follow-up intervals.
次要结局
未报告次要终点