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Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05767164
Enrollment
500
Registered
2023-03-14
Start date
2023-01-01
Completion date
2026-12-31
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spinal Stenosis

Keywords

Cervical single open-door surgery, Cervical Spinal Stenosis, Open angle

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

Interventions

PROCEDUREcervical single open-door surgery

The patients were operated by the cervical single open-door surgery, which were used with the Centerpiece titanium plate to internal fixation.

Sponsors

Xijing Hospital
Lead SponsorOTHER
Xi'an Honghui Hospital
CollaboratorOTHER
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
Tang-Du Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
lamina open angle3 months after surgeryThe Angle of opening of the cervical unilateral lamina while cervical single open-door surgery
JOA score changepre-operation,3 months after surgery, 1 year after surgeryJapanese 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 changepre-operation,3 months after surgery, 1 year after surgeryNeck 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 changepre-operation,3 months after surgeryA 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

MeasureTime frameDescription
Maximum spinal cord compression changepre-operation,3 months after surgery, 1 year after surgeryThis 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 changepre-operation,3 months after surgery, 1 year after surgeryThis 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 changepre-operation,3 months after surgery, 1 year after surgeryThis index was measured by MRI, which means the cross-sectional area of the cervical pulp at the highest level of compression.
Sagittal Canal Diameter changepre-operation,3 months after surgery, 1 year after surgeryThis index was measured by CT, which was sagittal diameter of the spinal canal at the most compressed level.

Countries

China

Contacts

CONTACTYanyan Jia
xiyyllwyh@163.com+862984771794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026