A small sample, single center, non-randomized, noninferiority clinical trial to evaluate the safety and effectiveness of 3D printed biodegradable cervical interbody fusion cage in anterior cervical discectomy and fusion (ACDF) for treating patients with a symptomatic degenerative cervical disc disease at one level from C2/C4 to C7/T1.
The study will evaluate if 3D printed biodegradable cervical interbody fusion cage is non-inferior to poly-ether-ether-ketone (PEEK) cage in single-level ACDF with the use of local autologous bone. 3D printed biodegradable cervical interbody fusion cage is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C2/C4 disc space to the C7/T1 disc space. The material used to prepare the implant is a mixture of polycaprolactone (PCL) and tricalcium phosphate (TCP), which is called PCL-TCP. The implant has proper strength and connective porosity. The PCL-TCP cage is intended to be used with a supplemental fixation system.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
ACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
Xijing Hospital
Xi'an, Shaanxi, China
Radiologic evaluation
Radiologic fusion assessed by roentgenographic examination or CT scan
Time frame: 12 months
Japanese Orthopaedic Association Scores (JOA scores)
The whole name is Japanese Orthopaedic Association Scores for Assessment of Cervical spondylosis, the range of JOA is 0-17 and the full score is 17 to represent a normal function.
Time frame: 12 months
Measurement of Pain: Visual Analog Scale (VAS)
The whole name is Visual Analog Scale which is ranged from 0-10, with 0 being the least and 10 being the worst pain experienced.
Time frame: 12 months
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