Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05786313

Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis

To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.

Recruiting

Interested in participating?

Request Info

Key information

Age range

28 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qi Wei

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

  • The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery.
  • No contraindications in preoperative routine tests and examinations.
  • Informed consent of patients.

Exclusion criteria

  • Cervical radiculopathy
  • Cervical kyphosis or instability
  • Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases
  • Revision surgery or combined anterior-posterior surgery is required
  • Serious neurological diseases affect the postoperative effect evaluation
  • Mental illness cannot cooperate with follow-up
  • Contraindications for MRI examination
  • Patients themselves or their families do not agree to participate in the study
  • Other situations that are not suitable for study participation.

Treatment and study plan

Centerpiece titanium plate

Procedure

All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.

Primary outcomes

  1. JOA score change

    Time frame: pre-operation,3 months after surgery, 6 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%.

  2. NDI score change

    Time frame: pre-operation,3 months after surgery, 6 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 program 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.

  3. VAS score

    Time frame: pre-operation,3 months after surgery, 6 months after surgery, 1 year 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, 6 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, 6 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, 6 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.

Study contacts

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 27, 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.

Published trials that share one or more normalized conditions with this study.