The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
The ACDF surgery will be carried out with NovoMax™ after randomization procedure.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Bone Fusion With CT and Dynamic radiographs(X-ray)(Post operative 6 Months)
Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT and X-ray at 6 months after operation (ACDF).
Time frame: at 6 months after surgery (ACDF)
VAS of Neck Pain(Post operative 6 Months)
Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF). Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled "no pain (zero point)" at the far left and "greatest pain (ten point)" at the far right.
Time frame: at 6 months after surgery (ACDF)
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