vertebral fracture, lumbar canal stenosis, lumbar spondylolisthesis, adult spine deformity
Conditions
Interventions
A lumbar lateral interbody fusion is performed by the spinal cage with unidirectional beta-tricalcium phosphate (beta-TCP) artificial bone impregnating platelet-rich plasma (PRP) prepared from the pa
Sponsors
Yamazaki Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who receives lateral lumbar interbody fusion surgery for vertebral fracture, lumbar canal stenosis, lumbar spondylolisthesis, adult spine deformity, and so on 2. Patients who receives lateral lumbar interbody fusion surgery at 1-4 levels 3. Patients over 20 years old 4. Patients with informed concent and understanding for treatment
Exclusion criteria
Exclusion criteria: 1. Patients with a history of lumbar surgery, purulent spondylitis, or spinal tumor 2. Patients who received other Investigational new drug within 3 months of participating in this clinical study 3. Patients who have a primary illness that is clearly inferior to bone formation (bone metabolic disease, dialysis, and so on) 4. Patients who have uncontrolled diabetes 5. Patients with anemia (Hb<9.0g/dL) 6. Patients who have disorder of blood coagulation. 7. Patients with rheumatoid arthritis who are using biologics with high risk of perioperative infection. 8. Women who are pregnant or suspected ofbeing pregnant or breastfeeding 9. Patients with metal allergy 10. Patients who needs the legal representative 11. Patients who are judged inappropriate by the responsible doctor for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interbody fusion rate at postoperative 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Interbody fusion rate at postoperative 6 months 2. bone remodeling and Absorption of artificial bone 3. Contact between the implanted beta- TCP and both upper and lower vertebral endplate 4. Clinical outcomes 5. back pain (Visual analog scale) | — |
Countries
Japan
Contacts
Public ContactHiroshi Noguchi
University of Tsukuba Hospital
Outcome results
None listed