Custom made LLIF artificial bone
- Conditions
- Degenerative lumbar diseaseslumbar spine, degenerative disease
- Registration Number
- JPRN-jRCTs052210067
- Lead Sponsor
- Fujibayashi Shunsuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 3
The main complaints are lumbar disc disease, lumbar spondylolisthesis, lumbar spinal canal stenosis, low back pain due to osteoporotic vertebral body fracture, nerve root symptoms, and cauda equina symptoms that do not improve with conservative treatment (physical therapy or drug therapy) for 3 months or longer. Cases for which LLIF surgery is indicated and shape compatibility cannot be obtained with existing cages.
Other spinal lesions such as cervical and thoracic spine disorders that require treatment
Systemic autoimmune diseases such as rheumatoid arthritis
Complications that are judged to seriously interfere with the execution of clinical trials (uncontrollable diabetes and hypertension, serious heart disease, respiratory disease, etc.)
Malignant tumor with no disease period within 5 years
Mental illness or psychiatric symptoms that may be difficult to participate in clinical trials
Bacterial infectious diseases of clinical problem
Diseases that require continuous systemic administration of steroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Occurrence of adverse events<br>2)Improvement of symptoms
- Secondary Outcome Measures
Name Time Method 1)Avoiding autologous iliac bone graft<br>2)Proper placement of test device<br>3)Bony union of test device<br>4)Acquisition and maintenance of spinal alignment