Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

NCT ID: NCT04167878

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2030-12-30

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.

Conditions

Symptomatic Cervical Disc Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACDF with 3D printed biodegradable cervical fusion cage

A resorbable cervical interbody cage made of PCL-TCP.

Group Type: EXPERIMENTAL

3D printed biodegradable cervical fusion cage

Intervention Type: DEVICE

ACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.

ACDF with PEEK cage

A structural PEEK cage with autologous bone.

Group Type: ACTIVE_COMPARATOR

PEEK cage

Intervention Type: DEVICE

ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.

Interventions

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.

Intervention Type: DEVICE

PEEK cage

ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.

Intervention Type: DEVICE

Other Intervention Names

3D printed PCL-TCP cage

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zheng Guo, doctor

Role: PRINCIPAL_INVESTIGATOR

Department of orthopedics， Xijing Hospital

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KY20192002-F-2

Identifier Type: -

Identifier Source: org_study_id