Clinical trial NCT05767164: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spinal Stenosis
Keywords: Cervical single open-door surgery
Cervical Spinal Stenosis
Open angle
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Xi'an Honghui Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Tang-Du Hospital
First posted: 2023-03-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: lamina open angle
timeFrame: 3 months after surgery
measure: JOA score change
timeFrame: pre-operation,3 months after surgery, 1 year after surgery
measure: NDI score change
timeFrame: pre-operation,3 months after surgery, 1 year after surgery
measure: VAS score change
timeFrame: pre-operation,3 months after surgery
Secondary outcomes:
measure: Maximum spinal cord compression change
timeFrame: pre-operation,3 months after surgery, 1 year after surgery
measure: Compression ratio change
timeFrame: pre-operation,3 months after surgery, 1 year after surgery
measure: transverse area change
timeFrame: pre-operation,3 months after surgery, 1 year after surgery
measure: Sagittal Canal Diameter change
timeFrame: pre-operation,3 months after surgery, 1 year after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shannxi Province
Study officials:
References:
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