Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

NCT04167878 | Active Not Recruiting DMC

• 1 other identifier: KY20192002-F-2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Cervical Disc Disease

Outcome Measures

Primary Outcomes (1)

• Radiologic evaluation

  Radiologic fusion assessed by roentgenographic examination or CT scan

  12 months

Secondary Outcomes (2)

• Japanese Orthopaedic Association Scores (JOA scores)

  12 months

• Measurement of Pain: Visual Analog Scale (VAS)

  12 months

Study Arms (2)

ACDF with 3D printed biodegradable cervical fusion cage

EXPERIMENTAL

A resorbable cervical interbody cage made of PCL-TCP.

Device: 3D printed biodegradable cervical fusion cage

ACDF with PEEK cage

ACTIVE COMPARATOR

A structural PEEK cage with autologous bone.

Device: PEEK cage

Interventions

3D printed biodegradable cervical fusion cage DEVICE

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

Also known as: 3D printed PCL-TCP cage

ACDF with 3D printed biodegradable cervical fusion cage

PEEK cage DEVICE

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

ACDF with PEEK cage

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Study Officials

• Zheng Guo, doctor

  Department of orthopedics， Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 5 couple， 10 patients will be assigned into investigational (n=5) and control groups (n=5).

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 19, 2019
• Study Start: December 1, 2019
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2030
• Last Updated: July 20, 2025

Record last verified: 2025-06

Locations

CN (1)