Symptomatic Cervical Disc DiseaseNCT04167878
Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage
A study testing 3D printed biodegradable cervical fusion cage and PEEK cage in people with Symptomatic Cervical Disc Disease, run by Xijing Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Symptomatic Cervical Disc Disease
- What is being tested?
- 3D printed biodegradable cervical fusion cage and PEEK cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Printed Biodegradable Cervical Interbody Fusion Cage in Anterior Cervical Discectomy and Fusion，a Small Sample and Exploratory Research
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.
Read the 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
- Being tested
- 3D printed biodegradable cervical fusion cage, PEEK cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed biodegradable cervical fusion cageDevice
Also called 3D printed PCL-TCP 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 cageDevice
ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
| Study group | Role | What they receive |
|---|---|---|
| ACDF with 3D printed biodegradable cervical fusion cage | Experimental | A resorbable cervical interbody cage made of PCL-TCP. Receives: Device: 3D printed biodegradable cervical fusion cage |
| ACDF with PEEK cage | Active comparator | A structural PEEK cage with autologous bone. Receives: Device: PEEK cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic evaluation
Radiologic fusion assessed by roentgenographic examination or CT scan
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Dec 2019
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Cervical Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A total of 5 couple， 10 patients will be assigned into investigational (n=5) and control groups (n=5).
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zheng Guo, doctor, Principal investigator, Department of orthopedics， Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167878
- Sponsor's protocol ID
- KY20192002-F-2
- Status last verified
- Jun 2025
- First submitted
- 8 Nov 2019
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Biodegradable Cervical Interbody Fusion Cage in Anterior Cervical Discectomy and Fusion，a Small Sample and Exploratory Research
- ClinicalTrials.gov ID
- NCT04167878
- Acronym / sponsor ID
- KY20192002-F-2
- Conditions
- Symptomatic Cervical Disc Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 5 couple， 10 patients will be assigned into investigational (n=5) and control groups (n=5).
| Arm | Type | Receives |
|---|---|---|
| ACDF with 3D printed biodegradable cervical fusion cage | Experimental | Device: 3D printed biodegradable cervical fusion cageA resorbable cervical interbody cage made of PCL-TCP. |
| ACDF with PEEK cage | Active comparator | Device: PEEK cageA structural PEEK cage with autologous bone. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed biodegradable cervical fusion cageAlso: 3D printed PCL-TCP cageACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine. | Device | ACDF with 3D printed biodegradable cervical fusion cage |
| PEEK cageACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine. | Device | ACDF with PEEK cage |
Primary outcome
Radiologic evaluation
Time frame: 12 months
Radiologic fusion assessed by roentgenographic examination or CT scan
2 secondary outcomes
Japanese Orthopaedic Association Scores (JOA scores)
Time frame: 12 months
Measurement of Pain: Visual Analog Scale (VAS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Guo, doctor principal investigator
Department of orthopedics， Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed biodegradable cervical fusion cage and PEEK cage in people with Symptomatic Cervical Disc Disease, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologic evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.