ISRCTN99263604招募中不适用
Clinical and radiological effect of cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
研究概览
简要总结
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29463278
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Clinical signs of lumbar degenerative stenotic disease from L1 to S1
- •2. MRI and CT confirmed: central canal stenosis OR lateral recesses stenosis OR foraminal stenosis leading to:
- •2.1. Radiculopathy, defined as pain and/or motor weakness or paralysis and/or paraestethica in a at least one specific nerve root distribution from L1 to S1 or
- •2.2. Neurogenic intermittent claudication, defined as pain and/or weakness and/or abnormal sensation in the legs during walking or prolonged standing
- •3. Indicating decompressive surgery and instrumented mono-, bi- or trisegmental spondylodesis with posterior instrumented fusion system and an intervertebral cage (TLIF)
- •4. Unresponsive to non-operative treatment for a minimum of 3 months including at least physiotherapy, pain medication and local infiltration therapy
- •5. Presence of progressive symptoms or signs of nerve root and/or spinal cord compression although performing conservative treatment
- •6. Aged between 18 and 85 years
排除标准
- •1. Previous surgery: Any instrumented lumbar spinal surgery, cervical and/or thoracic spinal disease to the extent that surgical consideration is likely or anticipated within 6 months after the lumbar surgical treatment
- •2. Other degenerative joint diseases (i.e. shoulder, hip knee) to the extent that surgical consideration is likely or anticipated within 6 months after or before the lumbar surgical treatment
- •3. Any other physical diseases (e.g. neuromuscular disorders) before and/or within 6 months after lumbar surgical intervention which are able to restrict study procedures (i.e. wheelchair bound) or preclude accurate clinical examination or outcome
- •4. Adipositas, severe obesity (BMI > 35 kg/m2)
- •5. Neoplasia as the source of symptoms
- •6. Fixed or permanent neurological deficit unrelated to the lumbar spine disease
- •7. Active or chronic infection, systemic or local, including HIV, AIDS, Hepatitis
- •8. 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
- •9. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis)
- •10. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia)
- •11. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
- •12. Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs)
- •13. Known allergy to titanium, Carbon/PEEK and tantalum or intolerance to any device material)
研究者
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