Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-85
SponsorXijing Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Centerpiece titanium plate
Procedure/SurgeryAll indexes were collected from the patients with Centerpiece titanium plate for internal fixation.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Centerpiece titanium plateActive comparator 1 intervention
Group B: 3D printed arch titanium plateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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, 6 months after surgery, 1 year after surgery2
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.
Time frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery3
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.
Time frame
pre-operation,3 months after surgery, 6 months after surgery, 1 year 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, 6 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, 6 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, 6 months after surgery, 1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov