Qi Wei
Xi'an, Shannxi Province, 710034, China
Location status: Recruiting
NCT Number: NCT05786313
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.
Interested in participating?
Request Info28 year–85 year
All sexes
Interventional
Not applicable
Xi'an, Shannxi Province, 710034, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.
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%.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Xijing Hospital
Other
Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
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.
NCT05767164
Cervical Spinal Stenosis
Xi'an, Shannxi Province, China
View Trial DetailsNCT05895968
Barbed Suture, Cervical Spinal Stenosis
Xi'an, Shannxi Province, China
View Trial DetailsNCT07604935
Cervical Spinal Stenosis, Neck Pain
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT06092138
Bone Diseases, Cervical Disc Herniation
Beijing, Beijing Municipality, China
View Trial Details