NCT06093087尚未招募1 期
Internal Fixation Reconstruction With Stent Screw VS Balloon Kyphoplasty in the Treatment of Kummell's Disease: a Double Blinded Randomized Controlled Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 70 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- ODI score
研究概览
简要总结
This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 or above, gender not specified.
- •Must have one to three vertebral segments with vertebral compression fracture (VCF) located between T5 and L5, attributed to underlying primary or secondary osteoporosis rather than cancer.
- •All VCFs must exhibit the following radiographic changes: according to Genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous X-ray, CT, or MRI results.
- •All VCFs for treatment must occur within four months or less.
- •All VCFs for treatment must be technically feasible and clinically suitable for BKP or SAIF surgery.
- •Pre-treatment back pain NRS score must be ≥ 7 and ineffective with conservative (non-surgical) treatment.
- •Pre-treatment Oswestry Disability Index must be ≥ 30 (on a scale of 0-100).
- •Patient's life expectancy must be ≥ 12 months.
- •Must declare willingness to participate in all post-operative follow-ups.
- •Must be capable of understanding the risks and benefits of the study and willing to provide written informed consent.
排除标准
- •Vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. VCF caused by high-energy trauma.
- •Asymptomatic VCF or vertebral bodies amenable to prophylactic treatment.
- •VCF at the same site associated with primary bone tumors.
- •Back pain caused by reasons other than acute fractures. VCF with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history).
- •VCF associated with secondary radiculopathy or neurological compromise.
- •VCF requiring spinal surgery other than BKP or SAIF.
- •Spinal cord compression or vertebral canal injury requiring decompression surgery.
- •Combined clinical conditions unsuitable for surgery or affecting subsequent long-term data collection or follow-up.
- •Allergy to any component during the surgical procedure (e.g., bone cement, contrast agents).
- •Concurrent participation in another clinical study.
- •Pregnancy during the study or planning to become pregnant.
结局指标
主要结局
ODI score
时间窗: ODI score measured 1,3,6 months post surgery during follow up
Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up
次要结局
- SF36 score(measured 1,3,6 months post surgery during follow up)
- EQ-5D score(measured 1,3,6 months post surgery during follow up)
- CT imaging indicators related to vertebral body stability(all variables were measured 1,3,6 months post surgery during follow up)
- VAS score(measured 1,3,6 months post surgery during follow up)
研究者
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