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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACDF with 3D printed biodegradable cervical fusion cage | Experimental | A resorbable cervical interbody cage made of PCL-TCP. |
|
| ACDF with PEEK cage | Active Comparator | A structural PEEK cage with autologous bone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed biodegradable cervical fusion cage | Device | ACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic evaluation | Radiologic fusion assessed by roentgenographic examination or CT scan | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measurement of Pain: Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zheng Guo, doctor | Department of orthopedics, Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
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A total of 5 couple, 10 patients will be assigned into investigational (n=5) and control groups (n=5).
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|
| PEEK cage | Device | ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine. |
|
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. |
| 12 months |