Cervical Spinal StenosisNCT05786313
Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis
A study testing Centerpiece titanium plate in people with Cervical Spinal Stenosis and Cervical Spinal Cord Injury, run by Xijing Hospital at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis. Read more about this study
- Who is it for?
- Ages 28 to 85 years
- Conditions the study is for
- Cervical Spinal Stenosis, Cervical Spinal Cord Injury, Individuation
- What is being tested?
- Centerpiece titanium plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2026
- 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 28 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery.
- No contraindications in preoperative routine tests and examinations.
- Informed consent of patients.
Who cannot join
- Cervical radiculopathy
- Cervical kyphosis or instability
- Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases
- Revision surgery or combined anterior-posterior surgery is required
- Serious neurological diseases affect the postoperative effect evaluation
- Mental illness cannot cooperate with follow-up
Show all 9Show fewer
- Contraindications for MRI examination
- Patients themselves or their families do not agree to participate in the study
- Other situations that are not suitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qi Wei
Xi'an, Shannxi Province, 710034
Wei Qi, Doctor, 15902984776, 14556263@qq.com
About this study
Official title: Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.
- Being tested
- Centerpiece titanium plate
- Keywords
- cervical spinal stenosis, open angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centerpiece titanium plateProcedure or surgery
All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.
| Study group | Role | What they receive |
|---|---|---|
| Centerpiece titanium plate | Active comparator | All surgical operations were performed by the same group of senior spine surgeons. The range of open door decompression involved C3 ~ C7. For convenient operation and more accurate statistics, the right side of the door axis and the left side of the door seam were selected for all operations. Centerpiece titanium plates were used for intraoperative fixation. Receives: Procedure: Centerpiece titanium plate |
| 3D printed arch titanium plate | Experimental | Before surgery, according to the imaging results, according to the effective imaging indicators screened in the early stage and the calculated door opening Angle formula, the door opening Angle of the patient's posterior cervical vertebra and the size of the fitted arch titanium plate were designed by mimics 10.0 software, and the titanium plate was printed using 3D printing technology. During the operation, the developed laminae opener was used to accurately control the door opening Angle and appropriate size titanium plate was installed for internal fixation. The standardized laminae door opening guide was used to complete the preparation of the door shaft side and door opening side of the lamina Receives: Procedure: Centerpiece titanium plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
JOA score change
Japanese Orthopedic Association (JOA) score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.
Measured: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
NDI score change
Neck Disability Index (NDI) score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of program X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.
Measured: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
VAS score
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary outcomes (3)
Maximum spinal cord compression change
This index was measured by MRI, which was the ratio of the diameter of the cervical pulp at the most compressed segment to the mean diameter of the cervical pulp at the upper and lower segments without compression.
Measured: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Compression ratio change
This index was measured by MRI, which means the minimum sagittal diameter of the cervical pulp in the most compressed segment divided by maximum transverse diameter.
Measured: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Transverse area change
This index was measured by MRI, which means the cross-sectional area of the cervical pulp at the highest level of compression.
Measured: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical Spinal StenosisStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786313
- Sponsor's protocol ID
- KY20222309-F-1
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmeiser G, Bergmann JI, Papavero L, Kothe R. Surgical Treatment of Multilevel Degenerative Cervical Myelopathy: Open-Door Laminoplasty and Fixation via Unilateral Approach. A Feasibility Study. J Neurol Surg A Cent Eur Neurosurg. 2022 Sep;83(5):494-501. doi: 10.1055/s-0041-1739224. Epub 2021 Dec 15.
PubMed 34911089Yeh KT, Lee RP, Chen IH, Yu TC, Liu KL, Peng CH, Wang JH, Wu WT. Laminoplasty instead of laminectomy as a decompression method in posterior instrumented fusion for degenerative cervical kyphosis with stenosis. J Orthop Surg Res. 2015 Sep 4;10:138. doi: 10.1186/s13018-015-0280-y.
PubMed 26338009Chen H, Liu H, Zou L, Li T, Gong Q, Song Y, Zeng J, Liu L, Kong Q. Effect of Mini-plate Fixation on Hinge Fracture and Bony Fusion in Unilateral Open-door Cervical Expansive Laminoplasty. Clin Spine Surg. 2016 Jul;29(6):E288-95. doi: 10.1097/BSD.0000000000000131.
PubMed 25023712Yuan W, Zhu Y, Liu X, Zhu H, Zhou X, Zhou R, Cui C, Li J. Postoperative three-dimensional cervical range of motion and neurological outcomes in patients with cervical ossification of the posterior longitudinal ligament: Cervical laminoplasty versus laminectomy with fusion. Clin Neurol Neurosurg. 2015 Jul;134:17-23. doi: 10.1016/j.clineuro.2015.04.004. Epub 2015 Apr 17.
PubMed 25929463
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
- ClinicalTrials.gov ID
- NCT05786313
- Acronym / sponsor ID
- KY20222309-F-1
- Keywords
- cervical spinal stenosis, open angle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2023 (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.
To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Centerpiece titanium plate | Active comparator | Procedure: Centerpiece titanium plateAll surgical operations were performed by the same group of senior spine surgeons. The range of open door decompression involved C3 ~ C7. For convenient operation and more accurate statistics, the right side of the door axis and the left side of the door seam were selected for all operations. Centerpiece titanium plates were used for intraoperative fixation. |
| 3D printed arch titanium plate | Experimental | Procedure: Centerpiece titanium plateBefore surgery, according to the imaging results, according to the effective imaging indicators screened in the early stage and the calculated door opening Angle formula, the door opening Angle of the patient's posterior cervical vertebra and the size of the fitted arch titanium plate were designed by mimics 10.0 software, and the titanium plate was printed using 3D printing technology. During the operation, the developed laminae opener was used to accurately control the door opening Angle and appropriate size titanium plate was installed for internal fixation. The standardized laminae door opening guide was used to complete the preparation of the door shaft side and door opening side of the lamina |
Who may qualify
- Ages
- 28 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery.
- No contraindications in preoperative routine tests and examinations.
- Informed consent of patients.
Key exclusion criteria (9 listed)
- Cervical radiculopathy
- Cervical kyphosis or instability
- Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases
- Revision surgery or combined anterior-posterior surgery is required
- Serious neurological diseases affect the postoperative effect evaluation
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 |
|---|---|---|
| Centerpiece titanium plateAll indexes were collected from the patients with Centerpiece titanium plate for internal fixation. | Procedure or surgery | 3D printed arch titanium plate, Centerpiece titanium plate |
Primary outcome
JOA score change
Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Japanese Orthopedic Association (JOA) score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.
NDI score change
Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Neck Disability Index (NDI) score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of program X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.
VAS score
Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
3 secondary outcomes
Maximum spinal cord compression change
Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Compression ratio change
Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Transverse area change
Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
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 30 Jul 2026.
- Background: PubMed 34911089Schmeiser G, Bergmann JI, Papavero L, Kothe R. Surgical Treatment of Multilevel Degenerative Cervical Myelopathy: Open-Door Laminoplasty and Fixation via Unilateral Approach. A Feasibility Study. J Neurol Surg A Cent Eur Neurosurg. 2022 Sep;83(5):494-501. doi: 10.1055/s-0041-1739224. Epub 2021 Dec 15.
- Background: PubMed 26338009Yeh KT, Lee RP, Chen IH, Yu TC, Liu KL, Peng CH, Wang JH, Wu WT. Laminoplasty instead of laminectomy as a decompression method in posterior instrumented fusion for degenerative cervical kyphosis with stenosis. J Orthop Surg Res. 2015 Sep 4;10:138. doi: 10.1186/s13018-015-0280-y.
- Background: PubMed 25023712Chen H, Liu H, Zou L, Li T, Gong Q, Song Y, Zeng J, Liu L, Kong Q. Effect of Mini-plate Fixation on Hinge Fracture and Bony Fusion in Unilateral Open-door Cervical Expansive Laminoplasty. Clin Spine Surg. 2016 Jul;29(6):E288-95. doi: 10.1097/BSD.0000000000000131.
- Background: PubMed 25929463Yuan W, Zhu Y, Liu X, Zhu H, Zhou X, Zhou R, Cui C, Li J. Postoperative three-dimensional cervical range of motion and neurological outcomes in patients with cervical ossification of the posterior longitudinal ligament: Cervical laminoplasty versus laminectomy with fusion. Clin Neurol Neurosurg. 2015 Jul;134:17-23. doi: 10.1016/j.clineuro.2015.04.004. Epub 2015 Apr 17.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centerpiece titanium plate in people with Cervical Spinal Stenosis and Cervical Spinal Cord Injury, 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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?
Contact Wei Qi (+862984771012, 14556263@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JOA score change (time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786313, which also lists 4 linked publications.
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 30 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.