NCT01316211已完成不适用
Comparative Evaluation of Clinical Outcome in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex™ Interlaminar Technology
Paradigm Spine16 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 16
- 主要终点
- Change in ODI From Baseline to 24 Months
研究概览
简要总结
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology
详细描述
The coflex® implant for interlaminar stabilization has been in clinical use for more than 10 years and is CE-certified according to the standards and approved in the United States.
This was a randomized multicenter study to collect prospective data for potential improvement in the therapy of low back pain during the treatment of spinal stenosis. The study was conducted in Germany.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, with constriction of the central spinal canal of one or two adjacent segments in the region L3 to L5 with the need for decompression.
- •If necessary additional decompression in the adjacent segment(s) may be performed avoiding any instability in the affected segment.
- •In addition the following may exist (but is not obligatory):
- •hypertrophy of the facet joints and subarticular recessus stenosis in the relevant segment or
- •stenosis of the foramen in the relevant segment
- •and/or stable retrolisthesis up to grade I verified by flexion-/extension X-ray films.
- •Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
- •VAS back pain score of at least 50 mm on a 100 mm scale (for acute back pain or a period of at least 3 month of back pain before the onset of leg pain).
- •Minimum of 3 months conservative therapy without improvement of symptoms.
- •Age >40 years.
- •Oswestry Low Back Pain Disability Questionnaire score of at least 18/45 (40%) for German sites or 20/50 (40%) for the US sites (The question about sexual life will be excluded).
- •Suitability of the patient for a posterior surgery procedure.
- •Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan, fill in of CRF pages and further study procedures.
- •Personally signed informed consent form before the start of any study related procedures.
排除标准
- •Any of the following will exclude a subject from the study:
- •Preceding fusion or decompression surgery of the lumbar spine or preceding nucleotomy of the segments of concern (also if nucleotomy becomes necessary during surgery).
- •Radiographically confirmed damage of the vertebral body in the segment of concern in the lumbar spine (e.g. osteoporotic compression fracture or because of tumors)
- •Isthmic and degenerative spondylolisthesis (anterolisthesis; retrolisthesis > grade I) or spondylolysis (Pars fracture).
- •Degenerative lumbar scoliosis (> 25°).
- •Adipositas (obesity). Defined as a body mass index >
- •Pregnancy, or wish to get pregnant during the course of the study.
- •Known allergy for titanium and titanium alloys.
- •Fluoride infections - both systemic and local.
- •History of severe peripheral neuropathy.
- •Significant peripheral vascular disease (claudication intermittens ≥ stage 2b).
- •M. Paget or osteomalacia or other metabolic bone disorders.
- •Cauda equina syndrome.
- •Communicating diseases, including HIV, active hepatitis
- •Patients who are lawfully kept in an institution.
- •Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical trial or will not comply with requirements of the study.
- •Subjects who participated in a clinical observation or therapy with X-ray during the last 10 years.
- •Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety and effectiveness assessment of this trial.
结局指标
主要结局
Change in ODI From Baseline to 24 Months
时间窗: Baseline, 3, 12, and 24 months
The ODI, also known as the Oswestry Low Back Pain Disability Questionnaire is a questionnaire providing information on back and leg pain and the affects on managing everyday life by dividing questions into 10 sections. For this study, the questions on sexual activity will not be asked. The total possible score for each section is 0-5. The scores are then converted percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).
次要结局
- Number of Participants With Adverse Events - Operative Site(2 years)
- Neurological Status - Mean Change in Muscle Strength From Baseline to 24 Months(Baseline, Day 0 (Surgery), 3, 12, and 24 months)
- Neurological Status- Mean Change in Ilio Sacral Joint Affection Test From Baseline to 24 Months.(Baseline, Day 0 (Surgery), 3, 12, and 24 months)
- Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- Number of Participants With Significant Migration or Expulsion of the Implant(2 years)
- Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- The Percentage of Patients With Survival Probability as Assessed by Evaluating Treatment Failure in Both Groups..(2 years)
- Change of Symptoms- Zurich Claudication Questionnaire (ZCQ) After 24 Months Compared to Baseline.(Baseline, 3, 12, and 24 months)
- Number of Participants Receiving Epidural Injections(2 years)
- Neurological Status- Mean Change in Trendelenburg Sign Test From Baseline to 24 Months.(Baseline, Day 0 (Surgery), 3, 12, and 24 months)
- Change in Functionality- Zurich Claudication Questionnaire (ZCQ) From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- Assessment of Time to Symptoms Utilizing Walking Distance Test(2 years)
- Assessment of Neurological Status Using the Laségue Test or Straight Leg Raise Test- Change From Baseline to 24 Months(Baseline, Day 0 (Surgery), 3, 12, and 24 months)
研究者
研究点 (16)
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