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

Sponsor
Xijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767164
Collaborator
Xi'an Honghui Hospital (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), Tang-Du Hospital (Other)
500
1
4
36
13.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: cervical single open-door surgery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery: a Multicenter Retrospective Clinical Study
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Preoperative

Experimental: postoperative (3 months)

Procedure: cervical 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.

Experimental: postoperative (6 months)

Procedure: cervical 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.

Experimental: postoperative (1 year)

Procedure: cervical 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.

Outcome Measures

Primary Outcome Measures

  1. lamina open angle [3 months after surgery]

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

  2. JOA score change [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%.

  3. NDI score change [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.

  4. VAS score change [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.

Secondary Outcome Measures

  1. Maximum spinal cord compression change [pre-operation,3 months after surgery, 1 year after surgery]

    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

  2. Compression ratio change [pre-operation,3 months after surgery, 1 year after surgery]

    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

  3. transverse area change [pre-operation,3 months after surgery, 1 year after surgery]

    This index was measured by MRI, which means the cross-sectional area of the cervical pulp at the highest level of compression.

  4. Sagittal Canal Diameter change [pre-operation,3 months after surgery, 1 year after surgery]

    This index was measured by CT, which was sagittal diameter of the spinal canal at the most compressed level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 86 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xijing Hospital Xi'an Shannxi Province China 710034

Sponsors and Collaborators

  • Xijing Hospital
  • Xi'an Honghui Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Tang-Du Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05767164
Other Study ID Numbers:
  • KY20222157-C-1
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xijing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023