Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

Not Applicable

• Conditions: Symptomatic Cervical Disc Disease
• Interventions: Device: 3D printed biodegradable cervical fusion cage; Device: PEEK cage

• Registration Number: NCT04167878
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-17
• Study First Posted: 2019-11-19
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-11-29
• Study Start: 2019-12-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACDF with 3D printed biodegradable cervical fusion cage	3D printed biodegradable cervical fusion cage	A resorbable cervical interbody cage made of PCL-TCP.
ACDF with PEEK cage	PEEK cage	A structural PEEK cage with autologous bone.

Primary Outcome Measures

Name	Time	Method
Radiologic evaluation	12 months	Radiologic fusion assessed by roentgenographic examination or CT scan

Secondary Outcome Measures

Name	Time	Method
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.