Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage
NCT04167878 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-07-20
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
Interventions
- 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.
Sponsors & Collaborators
-
Xijing Hospital
lead OTHER
Principal Investigators
-
Zheng Guo, doctor · Department of orthopedics, Xijing Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-01
- Primary Completion
- 2027-12-30
- Completion
- 2030-12-30
Countries
- China
Study Locations
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