Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

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.

Inclusion criteria

• Skeletally mature patients aged between 25 and 85 years (inclusive);
• Symptomatic cervical disc disease (SCDD) in the vertebral level between C2/C3 to C7/T1, correlated with radiculopathy or myelopathy;
• Radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following: herniated nucleus pulposus, spondylosis or loss of disc height;
• Requires only one cervical vertebral level to be surgically treated;
• Failed at least 12 weeks of conservative treatment;
• Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee;
• No significant restrictions showed by the pre-surgical routine test and examination.

Exclusion criteria

• Skeletally immature patients;
• Prior radiation history at anterior cervical area;
• Prior surgery at the level to be treated;
• More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI
• Complication of ossification of the ligamentum flavum, and Ossification of the posterior longitudinal ligament;
• Clinically compromised vertebral bodies at the affected level(s) due to trauma or tuberculosis
• Severe osteoporosis;
• Active systemic or local infection;
• Participation in other investigational device or drug clinical trials within 3 months of surgery;
• Other patients whom the investigator believe not appropriate.