Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery
ConditionCervical Spinal Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-86
SponsorXijing Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
cervical single open-door surgery
Procedure/SurgeryThe patients were operated by the cervical single open-door surgery, which were used with the Centerpiece titanium plate to internal fixation.
Treatment groups
500 Participants
are divided into 4 treatment groupsGroup A: PreoperativeNo intervention 0 interventions
Group B: postoperative (3 months)Experimental treatment 1 intervention
Group C: postoperative (6 months)Experimental treatment 1 intervention
Group D: postoperative (1 year)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
lamina open angle
The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery
Time frame
3 months after surgery2
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%.
Time frame
pre-operation,3 months after surgery, 1 year after surgery3
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.
Time frame
pre-operation,3 months after surgery, 1 year after surgery4
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.
Time frame
pre-operation,3 months after surgerySecondary outcomes
1
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
Time frame
pre-operation,3 months after surgery, 1 year after surgery2
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
Time frame
pre-operation,3 months after surgery, 1 year after surgery3
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.
Time frame
pre-operation,3 months after surgery, 1 year after surgery4
Sagittal Canal Diameter change
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Xijing Hospital
Lead sponsor
Xi'an Honghui Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Tang-Du Hospital
Collaborator
Source ClinicalTrials.gov