Recruiting NCT05786313
Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Centerpiece titanium plate.
- Who it may be relevant to
- Registry conditions: Cervical Spinal Stenosis, Cervical Spinal Cord Injury, Individuation, Standardization. Basic parameters: 28 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
Overview
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.
Interventions
- Procedure Centerpiece titanium plate
All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.
Primary outcome measures
- JOA score change [Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery]
- NDI score change [Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery]
- VAS score [Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Qi Wei — Xi'an
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. PMID 34911089
- Yeh 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. PMID 26338009
- Chen 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. PMID 25023712
- Yuan 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. PMID 25929463
Identifiers
NCT: NCT05786313 · KY20222309-F-1