Symptomatic Cervical Disc Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICE3D printed biodegradable cervical fusion cage
ACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
DEVICEPEEK cage
ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
Sponsors
Xijing Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A total of 5 couple， 10 patients will be assigned into investigational (n=5) and control groups (n=5).
Eligibility
Sex/Gender
ALL
Age
25 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Skeletally mature patients aged between 25 and 85 years (inclusive); 2. Symptomatic cervical disc disease (SCDD) in the vertebral level between C2/C3 to C7/T1, correlated with radiculopathy or myelopathy; 3. Radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following: herniated nucleus pulposus, spondylosis or loss of disc height; 4. Requires only one cervical vertebral level to be surgically treated; 5. Failed at least 12 weeks of conservative treatment; 6. Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee; 7. No significant restrictions showed by the pre-surgical routine test and examination.
Exclusion criteria
1. Skeletally immature patients; 2. Prior radiation history at anterior cervical area; 3. Prior surgery at the level to be treated; 4. More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI 5. Complication of ossification of the ligamentum flavum, and Ossification of the posterior longitudinal ligament; 6. Clinically compromised vertebral bodies at the affected level(s) due to trauma or tuberculosis 7. Severe osteoporosis; 8. Active systemic or local infection; 9. Participation in other investigational device or drug clinical trials within 3 months of surgery; 10. Other patients whom the investigator believe not appropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiologic evaluation | 12 months | Radiologic fusion assessed by roentgenographic examination or CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Japanese Orthopaedic Association Scores (JOA scores) | 12 months | 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. |
| Measurement of Pain: Visual Analog Scale (VAS) | 12 months | 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. |
Countries
China
Outcome results
None listed