Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis

Cervical Spinal Cord Injury Clinical Trial

Official title:

Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786313
• Other study ID #: KY20222309-F-1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Xijing Hospital
• Contact: Wei Qi
• Phone: +862984771012
• Email: 14556263[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Cervical Spinal Stenosis
• Constriction, Pathologic
• Spinal Cord Injuries
• Spinal Stenosis

Intervention

Procedure:
• Centerpiece titanium plate
All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.

Locations

Country	Name	City	State
China	Qi Wei	Xi'an	Shannxi Province

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Primary	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.	pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Primary	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.	pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary	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.	pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary	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.	pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary	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.	pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery