Evaluation of the efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion to treat degenerative spinal disease: a protocol of prospective, randomized controlled, assessor-blinded, open-label, multicenter trial

Table 2 Evaluation schedule

Visit type	Screening	Operation	Follow-up
Visit	1	2	3	4	5
Visit week	− 4 ~ 0 weeks	0 ~ 2 days	12 weeks	24 weeks	52 weeks
			± 5 weeks	± 8 weeks	± 8 weeks
Trial description and consent	○
Demographic data^a	○
Physical examination	○
Vital sign	○
Laboratory test^b	○
Bone mineral density	○
Sampling for rhBMP-2 antibodies^c	○		○
Inclusion/Exclusion criteria	○	○
Randomization		○
Operation		○
Simple radiographs	○
Computed tomography					○
ODI	○		○	○	○
EuroQol-5-dimensions	○		○	○	○
VAS	○		○	○	○
Union rate evaluation^d					○
Concomitant drug		○	○	○	○
Adverse events		○	○	○	○

rhBMP-2 recombinant human bone morphogenetic protein-2; ODI Oswestry Disability Index; and VAS visual analog scale
^aBaseline patient characteristic, including past medical/surgical history, physical examination
^bincluding CBC, chemistry, urinalysis, urine HCG test
^cTest for BMP-2 antibody baseline. Applicable only to the rhBMP-2 control group after surgery
^dEvaluation in simple radiographs and CT by 2 independent orthopedic specialists who do not participate in this study process

ISSN: 1749-799X