A Prospective, Comparative Study to Evaluate Effectiveness of Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes from baseline in Oswestry Disability Index(ODI)
研究概览
简要总结
In this prospective study the investigators seek to evaluate clinical outcomes after repairing the defect of intervertebral disc with autologous BMSC/gelatin sponge during microendoscopic discectomy for participants of lumbar disc herniation.
详细描述
The participants with lumbar disc herniation diseases are treated by Microendoscopic discectomy, and they are divided into four groups depend on whether the defect is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge or not and whether the defect is sutured or not. In the first group,the defect of intervertebral disc is repaired with Autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge and sutured. In the second group, the defect of intervertebral disc is repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge but not sutured after discectomy. In the third group, the defect of intervertebral disc is sutured but not repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy. In the four group, the defect of intervertebral disc is neither sutured nor repaired with autologous Bone Marrow Stem Cell (BMSC)/gelatin sponge after discectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with signs and symptoms of lumbar disc herniation requiring surgical treatment after conservative management;
- •Radiological data on CT/MRI obtained within a period prior to enrollment;
- •Participants give written informed consent before enrollment.
排除标准
- •If participants had an incomplete medical record;
- •Participants had spine tumor, spine infection, previous underwent lumbar surgery, or revision surgery.
- •Participants are taking uninterruptible anticoagulation therapy.
- •Dementia and/or inability to give informed consent.
- •MRI contraindication (e.g. cerebral aneurysm clips, cochlear implants, pacemaker, implanted biostimulators);
- •Participation in other clinical trial within the last 30 days.
结局指标
主要结局
Changes from baseline in Oswestry Disability Index(ODI)
时间窗: Baseline, post-op 3 months, 6 months,12 months
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
次要结局
- Changes from baseline in Visual Analogue Scale(VAS)(Baseline, post-op 3 months, 6 months,12 months)
- Changes from baseline in The Short Form (36) Health Survey(SF-36)(Baseline, post-op 3 months, 6 months,12 months)
- Change from Baseline in The Size of Disc Protrusion(Baseline, post-op 12 months)
- Change from Baseline in Magnetic Resonance Classification of Lumbar Intervertebral Disc Degeneration（Pfirrmann classification）(Baseline, post-op 12 months)
- Change from Baseline in The Height of Disc on MRI Scans(Baseline, post-op 12 months)
研究者
Zhanghao
Tianjin Hospital
Tianjin Hospital