Clinical trial NCT05786313: Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis
Official title: Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spinal Stenosis
Cervical Spinal Cord Injury
Individuation
Standardization
Keywords: cervical spinal stenosis
open angle
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 500
Sex: ALL
Minimum age (years): 28
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: JOA score change
timeFrame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
measure: NDI score change
timeFrame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
measure: VAS score
timeFrame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary outcomes:
measure: Maximum spinal cord compression change
timeFrame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
measure: Compression ratio change
timeFrame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
measure: Transverse area change
timeFrame: pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Qi Wei
state: Shannxi Province
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.