NL-OMON30202招募中不适用
A pilot study to evaluate the Safety and Performance of the Percutaneuos Dynamic Stabilization (PDS) system for the treatment of mild to Moderate Degenerative Disc disease - PDS stabilization
mediqol0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients aged between 18 and 60 years of age inclusive.
- •Patients with evidence of mild to moderate degenerative disc disease at a single level of the lumbar spine (L 1 through to SI) confirmed by MRI within the last 6 months.
- •Patients with clinical evidence of degenerative disc disease experiencing back pain and confirmed by provocative discography at the target level.
- •Patients who have failed to adequately improve following a 3 month period of conservative management, who in the opinion of the Clinical Investigator, require surgical intervention or aggressive conservative management.
- •Patients who have a minimum baseline Oswestry Score of30% (15/50).
- •Patients who are able to give voluntary, \vritten informed consent to participate in this study and from whom consent has been obtained.
- •Patients, who, in the opinion of the Clinical Investigator, are able to understand this study, co-operate with the procedures and are willing to return to the hospital for all the required post-operatiw follOw'-up procedures.
排除标准
- •Patients who, in the opinion of the Clinical Investigator, haw 2.would compromise their participation and follow-up in this study.
- •Patients who have rheumatoid arthritis, lupus, osteoporosis (T<1.0) disease, osteomalacia, Paget's disease, other metabolic bone disease : syndrome.
- •Patients who have significant spondylosis, scoliosis, kyphosis or any oc~-condition which would compromise their participation.
- •Patients with evidence of tumour and/or malignant disease with resultant life expectancy of less than one year.
- •Patients who are immunocompromised or being treated with immunosuppressive agents.
- •and/or present with a significant general illness that decreases the probability of surviyal.
- •Patients who have leg pain without back pain ..
- •Patients with greater than 50% disc collapse as compared to adjacent discs.
- •Patients with Modic 2 or Modic 3 bone changes at the target level.
- •Patients with radiographic confirmation of severe facet joint disease or degeneration.
- •Patients with clinically compromised vertebral bodies at the affected level due to current
- •or past trauma like sustained pathological fracture or multiple fractures of vertebrae.
- •Patients with evidence of an active systemic infection or an infection at the target level.
- •Patients with a known allergy to titanium and/or polycarbonate urethane (PCD).
- •Subjects with concomitant conditions requiring steroid treatment or prior steroid usage within the last 3 months.
- •Patients who have previously had spine surgery performed at the target level or an adjacent level.
- •Patients who have previously participated in any experimental spinal implant or treatment.
- •Patients who have any injury litigation claims pending.
- •Patients who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
研究者
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