Cervical disorder (spondyloarthrosis, spinal osteoarthritis) Cervical spine, posterior fusion surgery
Conditions
Interventions
E04-270-40-10
Posterior fusion surgery
Sponsors
Yamazaki Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients undergoing posterior cervical spinal fusion(from C2 or C3 to C7 or T1 fusion) 2. 20 years old or more and less than 90 years old
Exclusion criteria
Exclusion criteria: 1. The patient who has past history of cervical surgery, pyogenic spondylitis, and vertebral tumor. 2. The patient who receives cervical anterior fusion surgery 3. The patient who received other study drugs within current three months 4. The diabetic that it is poor in control 5. The patient who cannot be inserted caudal end screw of fixed range 6. The patient who has a serious heart disorder 7. The patient who has a serious hepatic dysfunction(AST(GOT)or ALT(GPT) is more than 100u) 8. The patient who has a serious renal dysfunction(BUN is more than 25mg/dL or serum creatinine is more than 2.0 mg/dL) 9. The patient who has a doubt or diagnostic neoplastic lesion within 5 years before agreement. 10. The woman that during the pregnancy or the pregnancy is doubted 11. The woman that during breastfeed. 12. The patient who has an allergy to metal. 13. The patient who has an allergy to Fiblastspray. 14. The patient who has not ability for agreement with own will. 15. The patient who has not ability for agreement by the reading and writing 16. The patient who has been judged to be inappropriate as a subject by the doctor incharge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of all adverse events that occurred during the clinical trials such as infection, death, fracture, neoplasma, or neuropathy due to the Ap-FGF pedicle screws. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of loosening and breakage of each pedicle screw. Time for bone union JOA score, JOACMEQ | — |
Contacts
Public ContactYuki Hara
University of Tsukuba Hospital
Outcome results
None listed