Degenerative Lumbar Diseases
Conditions
Interventions
CBT:MIS-PLIF with CBT
PS:MIS-PLIF with PS
Sponsors
Department of Neurosurgery, Xuanwu Hospital, Capital Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 year old; 2. Clinical signs of low back pain and/or radiculopathy from vertebrae L1 to S1; 3. MRI and CT confirmed: central canal stenosis, lateral recesses stenosis, or foraminal stenosis leading to: 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. Psychosocial, mental and physical ability to understand and to perform with this protocol, especially visiting scheduled follow-up controls, observe treatment plan and all other study-related procedures.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.
Exclusion criteria
Exclusion criteria: 1. Previous surgery: (1) any instrumented lumbar spinal surgery, (2) cervical and/or (3) thoracic spinal disease treated with surgeries; 2. severe systemic diseases such as heart failure, cardiac infarction, renal failure, pulmonary infection et al.; 3. neurological deficits caused by previous cerebral vascular events; 4. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis, SLE et al.); 5. Malignancy as the source of symptoms; 6. Severe obesity (BMI >35 kg/m2); 7. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia); 8. Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs); 9. Known allergy to titanium, carbon/PEEK and tantalum or intolerance to any device material; 10. Do not agree with randomization or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ODI scale;JOA scale;VAS scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| operation time;blood loss;cost for operation;complication;bony fusion; | — |
Countries
China
Contacts
Public ContactZan Chen
Xuanwu Hospital, Capital Medical College
Outcome results
None listed