NCT04167878

Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-12-01
• Primary completion: 2027-12-30
• Completion: 2030-12-30
• First posted: 2019-11-19
• Last updated: 2025-07-20

Locations

1 site across 1 country: China