3D printed biodegradable cervical fusion cagePEEK cage
3D 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.
PEEK cage: ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
Study 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.
Eligibility
Sex
ALL
Min age
25 Years
Max age
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.
Primary outcome measure(s)
Radiologic evaluation — 12 months Radiologic fusion assessed by roentgenographic examination or CT scan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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