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Clinical Trials/NCT05767164
NCT05767164
Recruiting
Not Applicable

Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery: a Multicenter Retrospective Clinical Study

Xijing Hospital1 site in 1 country500 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Spinal Stenosis
Sponsor
Xijing Hospital
Enrollment
500
Locations
1
Primary Endpoint
NDI score change
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

NDI score change

Time Frame: pre-operation,3 months after surgery, 1 year after surgery

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

Time Frame: pre-operation,3 months after surgery

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.

lamina open angle

Time Frame: 3 months after surgery

The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery

JOA score change

Time Frame: pre-operation,3 months after surgery, 1 year after surgery

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%.

Secondary Outcomes

  • Compression ratio change(pre-operation,3 months after surgery, 1 year after surgery)
  • transverse area change(pre-operation,3 months after surgery, 1 year after surgery)
  • Maximum spinal cord compression change(pre-operation,3 months after surgery, 1 year after surgery)
  • Sagittal Canal Diameter change(pre-operation,3 months after surgery, 1 year after surgery)

Study Sites (1)

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