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 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Degenarative diseases
- 发起方
- mediqol
- 入组人数
- 24
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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