Degenerative lumbar diseases lumbar spine, degenerative disease
Conditions
Interventions
Perform lumbar spine surgery using patient-specific artificial bone, which is an unapproved medical device, and follow up for 1 year after surgery.operative intervention
Sponsors
Fujibayashi Shunsuke
G-Cube Co., Ltd.
Kyoto University Incubation Program
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Occurrence of adverse events 2)Improvement of symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Avoiding autologous iliac bone graft 2)Proper placement of test device 3)Bony union of test device 4)Acquisition and maintenance of spinal alignment | — |
Contacts
Public ContactShunsuke Fujibayashi
Kyoto University hospital
Outcome results
None listed