Ap-FGF-CPS trial

JRCT ID: jRCTs031180078

Registered date:11/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cervical disorder (spondyloarthrosis, spinal osteoarthritis)
• Date of first enrollment: 13/08/2018
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Ap-FGF coating pedicle screws are implanted in the caudal end of the fixation range at the time of the surgery

Outcome(s)

• Primary Outcome: 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 Outcome

Incidence of loosening and breakage of each pedicle screw.
Time for bone union
JOA score, JOACMEQ

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 89age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamazaki Masashi
• Source(s) of Monetary Support: Japan society for the promotion of science