Back to resultsStudy of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis
Primary Purpose
Cervical Spinal Stenosis, Cervical Spinal Cord Injury, Individuation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Centerpiece titanium plate
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spinal Stenosis focused on measuring cervical spinal stenosis, open angle
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.
Sites / Locations
- Qi WeiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Centerpiece titanium plate
3D printed arch titanium plate
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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%.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05786313
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Stenosis, Cervical Spinal Cord Injury, Individuation, Standardization
Keywords
cervical spinal stenosis, open angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Centerpiece titanium plate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3D printed arch titanium plate
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Centerpiece titanium plate
Intervention Description
All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.
Primary Outcome Measure Information:
Title
JOA score change
Description
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%.
Time Frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Title
NDI score change
Description
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.
Time Frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Title
VAS score
Description
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.
Time Frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Secondary Outcome Measure Information:
Title
Maximum spinal cord compression change
Description
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.
Time Frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Title
Compression ratio change
Description
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.
Time Frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
Title
Transverse area change
Description
This index was measured by MRI, which means the cross-sectional area of the cervical pulp at the highest level of compression.
Time Frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Qi
Phone
+862984771012
Email
14556263@qq.com
Facility Information:
Facility Name
Qi Wei
City
Xi'an
State/Province
Shannxi Province
ZIP/Postal Code
710034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Qi, Doctor
Phone
15902984776
Email
14556263@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34911089
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.
Results Reference
background
PubMed Identifier
26338009
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.
Results Reference
background
PubMed Identifier
25023712
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.
Results Reference
background
PubMed Identifier
25929463
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.
Results Reference
background
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Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis
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