Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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3D Printed Biodegradable Cervical Interbody Fusion Cage in Anterior Cervical Discectomy and Fusion，a Small Sample and Exploratory Research

Conditions
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Symptomatic Cervical Disc Disease

Intervention / Treatment
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* Device: 3D printed biodegradable cervical fusion cage
* Device: PEEK cage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 5 couple， 10 patients will be assigned into investigational (n=5) and control groups (n=5).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACDF with 3D printed biodegradable cervical fusion cage<br>A resorbable cervical interbody cage made of PCL-TCP. | Device: 3D printed biodegradable cervical fusion cage<br>* ACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.<br>* Other names: 3D printed PCL-TCP cage;|
| Active Comparator: ACDF with PEEK cage<br>A structural PEEK cage with autologous bone. | Device: PEEK cage<br>* ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic evaluation | Radiologic fusion assessed by roentgenographic examination or CT scan | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |