ISRCTN82578069招募中不适用
Comparison of posterior Foraminotomy and anterior foraminotomy with fusion for treating spondylotic foraminal stenosis of the Cervical spine: a randomized clinical trial
Innsbruck Medical University (Austria)0 个研究点目标入组 88 人开始时间: 2013年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
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
- 性别
- All
入选标准
- •1. Age between 18 - 80 years
- •2. Cervical spondylotic foraminal stenosis causing radiculopathy of C5 and/or C6 and/or C7 and requiring decompression of = 2 neuroforaminae
- •3. Radiculopathy is defined as pain, paralysis or paresthesia in corresponding nerve root distribution areas of C5 and/or C6 and/or C7, and must include at least arm/shoulder pain with minimum of 30 mm on 100 mm visual analogue scale (VAS)
- •4. Neck Disability Index (NDI) score = 30 out of 100
- •5. Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of nerve root compression in the face of conservative treatment
- •6. Magnetic resonance imaging (MRI) and computerised tomography (CT) determined spondylotic foraminal stenosis at treatment level/levels that correlate to primary symptoms
- •7. Appropriate candidate for treatment using both an anterior approach via ventral discectomy and fusion or a posterior approach via foraminotomy as described by Frykholm
- •8. Psychosocially, mentally and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms and other study procedures
- •9. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.
排除标准
- •Clinical criteria:
- •1. Previous cervical spinal surgery at index level
- •2. Lumbar or thoracic spinal disease to the extent that surgical consideration is likely or anticipated within 6 months after the cervical surgical treatment
- •3. Upper extremity degenerative joint diseases (i.e. shoulder) to the extent that:
- •3.1. Surgical consideration is likely or anticipated within 6 months after the cervical surgical treatment
- •3.2. The resulting pain is chronic (>3 months)
- •4. Axial neck pain in the absence of other symptoms of radiculopathy justifying the need for surgical intervention
- •5. Myelopathy
- •6. Neoplasia as the source of symptoms
- •7. Fixed or permanent neurological deficit unrelated to the cervical disc disease
- •8. Disease or conditions that preclude accurate clinical evaluation (e.g. neuromuscular disorders)
- •9. Active or chronic infection, systemic or local
- •10. Systemic disease including HIV, AIDS, hepatitis
- •11. Active malignancy defined as a history of any invasive malignancy, except non- melanoma skin cancer, unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for a minimum of 5 years
- •12. Paget?s disease, osteomalacia, or any other metabolic bone disease (for osteoporosis see below)
- •13. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis)
- •14. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia)
- •15. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
- •16. Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs)
- •17. Anticipated long-term use of systemic steroid medications postoperatively
- •Radiological criteria:
- •1. A symptomatic spondylotic foraminal stenosis - considered for surgical intervention, with a contralateral asymptomatic spondylotic foraminal stenoses at the same level with equal or higher extent in the CT exams
- •2. Cervical disc herniation or central canal stenosis causing radiculopathy or clinical myelopathy
- •3. Myelopathy in the MRI exams
- •4. Marked cervical instability on flexion/extension radiographs defined as: Translation > 3mm and/or Angulation > 20°
- •5. Kyphotic segmental angulation >11° at treatment or adjacent levels
- •Varia (Other):
- •1. Patient is currently pursuing personal litigation related to spinal diseases
- •2. Prisoner or ward of the state
- •3. Patient has used another investigational drug or device within the last 30 days prior to surgery
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