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Clinical Trials in China / NCT04167878
Active, not recruiting Not applicable

Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

NCT04167878 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital
Phase
Not applicable
Started
2019-12-01
Last updated
2025-07-20

Condition(s) studied

Symptomatic Cervical Disc Disease

Investigational drug(s) / intervention(s)

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)

Trial sites (1)

FacilityCityRegionStatus
Xijing Hospital Xi'an Shaanxi

More Xijing Hospital trials in China

Official registry record

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.

View NCT04167878 on ClinicalTrials.gov ↗ ← All trials in China