Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases: Study Protocol for a Prospective, Self-controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 67
- 主要终点
- Oswestry dysfunction index scores
研究概览
简要总结
To conduct a prospective, single-center, self-controlled, clinical trial to verify the efficacy and safety of K-Rod dynamic stability system in the repair of lumbar degenerative diseases following 2 years follow-up, aiming to provide references for clinical treatment of lumbar degenerative diseases.
详细描述
Posterior internal fixation and fusion systems are still one of the main methods for the treatment of chronic back pain due to intervertebral disc degeneration, but adverse reactions, such as accelerated regression of adjacent segments, are often inevitable during the treatment.
At present, various pedicle screw-based posterior dynamic stability systems of the lumbar spine have become an alternative fusion therapy for lumbar degenerative diseases. Dynamic stability is defined to reduce the loading on the intervertebral disc/articular surfaces, to maintain movement under mechanical load, to limit the abnormal movement of the spinal segment, and to reduce the stress on the bone-screw interface dynamically and stably. An ideal fixation system will be stable enough to maximize the fusion rate without the need for excessive rigidity, as well as to maintain maximum load and physiological posture of the vertebral segment, thereby reducing the horizontal stress of the adjacent segment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 32 Years 至 76 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Degenerative lumbar spondylolisthesis (degree I)
- •Nerve root canal or central spinal canal stenosis
- •Accompanying nerve root pain and/or chronic back pain
- •32-76 years old
- •Regardless of gender
- •All patients or family members signed the informed consent
排除标准
- •Systemic infection;
- •Poor compliance and inability to complete the trial
研究组 & 干预措施
trial group
Sixty-seven patients with lumbar degenerative diseases were treated with K-rod dynamic stabilization system. All patients were followed for 2 years.
干预措施: K-rod dynamic stabilization system (Device)
结局指标
主要结局
Oswestry dysfunction index scores
时间窗: at month 24 after surgery
To quantify disability for pain. The Oswestry Disability Index questionnaire contains ten questions concerning intensity of pain, ability to take care of oneself, lifting, ability to walk, ability to sit, ability to stand, sleep quality, sexual life, social life, and ability to travel. 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.
次要结局
- Lumbar lordosis angle(at month 24 after surgery)
研究者
Shuyi Gong
Principal Investigator
Shenyang Orthopedic Hospital
