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NCT Number: NCT05767164

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

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

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Key information

Conditions

Cervical Spinal Stenosis

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shannxi Province, 710034, China

Location status: Recruiting

Location contact

Wei Qi, Doctor

CONTACT

[email protected]

15902984776

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cervical single open-door surgery

Procedure

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

Primary outcomes

  1. lamina open angle

    Time frame: 3 months after surgery

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

  2. 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%.

  3. 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.

  4. 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.

Secondary outcomes

  1. Maximum spinal cord compression change

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanyan Jia

CONTACT

[email protected]

+862984771794

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 14, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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