Back to resultsCorrelation Between Parameters and Prognosis of Cervical Single Open-door Surgery
Primary Purpose
Cervical Spinal Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cervical single open-door surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spinal Stenosis focused on measuring Cervical single open-door surgery, Cervical Spinal Stenosis, Open angle
Eligibility Criteria
Inclusion Criteria: Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis. Conservative treatment for more than 3 months before surgery was ineffective. The patients underwent cervical single open-door surgery. Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery Exclusion Criteria: Cervical spondylotic radiculopathy. Cervical kyphosis or instability. Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases. Revision surgery or combined anterior-posterior surgery is required. The patients had severe neurological diseases affecting the evaluation of postoperative results. Psychopath. MRI or CT for contraindications.
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Preoperative
postoperative (3 months)
postoperative (6 months)
postoperative (1 year)
Arm Description
Outcomes
Primary Outcome Measures
lamina open angle
The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery
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 programme 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 change
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.
Sagittal Canal Diameter change
This index was measured by CT, which was sagittal diameter of the spinal canal at the most compressed level.
Full Information
NCT ID
NCT05767164
First Posted
February 18, 2023
Last Updated
March 1, 2023
Sponsor
Xijing Hospital
Collaborators
Xi'an Honghui Hospital, First Affiliated Hospital Xi'an Jiaotong University, Tang-Du Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05767164
Brief Title
Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery
Official Title
Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery: a Multicenter Retrospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Xi'an Honghui Hospital, First Affiliated Hospital Xi'an Jiaotong University, Tang-Du Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of study was evaluated the relationship between the relevant evaluation indexes of cervical spine open-door surgery, prognosis and complication rate, and provided theoretical basis for personalized surgical program through multi-center retrospective clinical study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Stenosis
Keywords
Cervical single open-door surgery, Cervical Spinal Stenosis, Open angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative
Arm Type
No Intervention
Arm Title
postoperative (3 months)
Arm Type
Experimental
Arm Title
postoperative (6 months)
Arm Type
Experimental
Arm Title
postoperative (1 year)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
cervical single open-door surgery
Intervention Description
The patients were operated by the cervical single open-door surgery, which were used with the Centerpiece titanium plate to internal fixation.
Primary Outcome Measure Information:
Title
lamina open angle
Description
The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery
Time Frame
3 months after surgery
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, 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 programme 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, 1 year after surgery
Title
VAS score change
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
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, 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, 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, 1 year after surgery
Title
Sagittal Canal Diameter change
Description
This index was measured by CT, which was sagittal diameter of the spinal canal at the most compressed level.
Time Frame
pre-operation,3 months after surgery, 1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
Conservative treatment for more than 3 months before surgery was ineffective.
The patients underwent cervical single open-door surgery.
Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery
Exclusion Criteria:
Cervical spondylotic radiculopathy.
Cervical kyphosis or instability.
Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases.
Revision surgery or combined anterior-posterior surgery is required.
The patients had severe neurological diseases affecting the evaluation of postoperative results.
Psychopath.
MRI or CT for contraindications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Jia
Phone
+862984771794
Email
xiyyllwyh@163.com
Facility Information:
Facility Name
Xijing Hospital
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
6792717
Citation
Hirabayashi K, Miyakawa J, Satomi K, Maruyama T, Wakano K. Operative results and postoperative progression of ossification among patients with ossification of cervical posterior longitudinal ligament. Spine (Phila Pa 1976). 1981 Jul-Aug;6(4):354-64. doi: 10.1097/00007632-198107000-00005.
Results Reference
background
PubMed Identifier
23448898
Citation
Karpova A, Arun R, Davis AM, Kulkarni AV, Massicotte EM, Mikulis DJ, Lubina ZI, Fehlings MG. Predictors of surgical outcome in cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Mar 1;38(5):392-400. doi: 10.1097/BRS.0b013e3182715bc3.
Results Reference
background
PubMed Identifier
25668335
Citation
Nouri A, Tetreault L, Zamorano JJ, Dalzell K, Davis AM, Mikulis D, Yee A, Fehlings MG. Role of magnetic resonance imaging in predicting surgical outcome in patients with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2015 Feb 1;40(3):171-8. doi: 10.1097/BRS.0000000000000678.
Results Reference
background
PubMed Identifier
3782207
Citation
Torg JS, Pavlov H, Genuario SE, Sennett B, Wisneski RJ, Robie BH, Jahre C. Neurapraxia of the cervical spinal cord with transient quadriplegia. J Bone Joint Surg Am. 1986 Dec;68(9):1354-70.
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
3615879
Citation
Pavlov H, Torg JS, Robie B, Jahre C. Cervical spinal stenosis: determination with vertebral body ratio method. Radiology. 1987 Sep;164(3):771-5. doi: 10.1148/radiology.164.3.3615879.
Results Reference
background
PubMed Identifier
10068016
Citation
Blackley HR, Plank LD, Robertson PA. Determining the sagittal dimensions of the canal of the cervical spine. The reliability of ratios of anatomical measurements. J Bone Joint Surg Br. 1999 Jan;81(1):110-2. doi: 10.1302/0301-620x.81b1.9001.
Results Reference
background
PubMed Identifier
12811269
Citation
Prasad SS, O'Malley M, Caplan M, Shackleford IM, Pydisetty RK. MRI measurements of the cervical spine and their correlation to Pavlov's ratio. Spine (Phila Pa 1976). 2003 Jun 15;28(12):1263-8. doi: 10.1097/01.BRS.0000065570.20888.AA.
Results Reference
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Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery
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