Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

Symptomatic Cervical Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04167878
• Other study ID #: KY20192002-F-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2019
• Source: Xijing Hospital
• Contact: Xiaokang Li, doctor
• Phone: 86-29-84775284
• Email: lxkfmmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Symptomatic Cervical Disc Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologic evaluation	Radiologic fusion assessed by roentgenographic examination or CT scan	12 months
Secondary	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
Secondary	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