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

Cervical Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767164
• Other study ID #: KY20222157-C-1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Xijing Hospital
• Contact: Yanyan Jia
• Phone: +862984771794
• Email: xiyyllwyh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spinal Stenosis
• Spinal Stenosis

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shannxi Province

Sponsors (4)

Lead Sponsor	Collaborator
Xijing Hospital	First Affiliated Hospital Xi'an Jiaotong University, Tang-Du Hospital, Xi'an Honghui Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Blackley HR, Plank LD, Robertson PA. Determining the sagittal dimensions of the canal of the cervical spine. The reliability of ratios of anatomical measurements. J Bone Joint Surg Br. 1999 Jan;81(1):110-2. doi: 10.1302/0301-620x.81b1.9001. — View Citation

Hirabayashi K, Miyakawa J, Satomi K, Maruyama T, Wakano K. Operative results and postoperative progression of ossification among patients with ossification of cervical posterior longitudinal ligament. Spine (Phila Pa 1976). 1981 Jul-Aug;6(4):354-64. doi: 10.1097/00007632-198107000-00005. — View Citation

Karpova A, Arun R, Davis AM, Kulkarni AV, Massicotte EM, Mikulis DJ, Lubina ZI, Fehlings MG. Predictors of surgical outcome in cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Mar 1;38(5):392-400. doi: 10.1097/BRS.0b013e3182715bc3. — View Citation

Nouri A, Tetreault L, Zamorano JJ, Dalzell K, Davis AM, Mikulis D, Yee A, Fehlings MG. Role of magnetic resonance imaging in predicting surgical outcome in patients with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2015 Feb 1;40(3):171-8. doi: 10.1097/BRS.0000000000000678. — View Citation

Pavlov H, Torg JS, Robie B, Jahre C. Cervical spinal stenosis: determination with vertebral body ratio method. Radiology. 1987 Sep;164(3):771-5. doi: 10.1148/radiology.164.3.3615879. — View Citation

Prasad SS, O'Malley M, Caplan M, Shackleford IM, Pydisetty RK. MRI measurements of the cervical spine and their correlation to Pavlov's ratio. Spine (Phila Pa 1976). 2003 Jun 15;28(12):1263-8. doi: 10.1097/01.BRS.0000065570.20888.AA. — View Citation

Torg JS, Pavlov H, Genuario SE, Sennett B, Wisneski RJ, Robie BH, Jahre C. Neurapraxia of the cervical spinal cord with transient quadriplegia. J Bone Joint Surg Am. 1986 Dec;68(9):1354-70. — View Citation

Yeh KT, Lee RP, Chen IH, Yu TC, Liu KL, Peng CH, Wang JH, Wu WT. Laminoplasty instead of laminectomy as a decompression method in posterior instrumented fusion for degenerative cervical kyphosis with stenosis. J Orthop Surg Res. 2015 Sep 4;10:138. doi: 10.1186/s13018-015-0280-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lamina open angle	The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery	3 months after surgery
Primary	JOA score change	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%.	pre-operation,3 months after surgery, 1 year after surgery
Primary	NDI score change	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.	pre-operation,3 months after surgery, 1 year after surgery
Primary	VAS score change	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.	pre-operation,3 months after surgery
Secondary	Maximum spinal cord compression change	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	pre-operation,3 months after surgery, 1 year after surgery
Secondary	Compression ratio change	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	pre-operation,3 months after surgery, 1 year after surgery
Secondary	transverse area change	This index was measured by MRI, which means the cross-sectional area of the cervical pulp at the highest level of compression.	pre-operation,3 months after surgery, 1 year after surgery
Secondary	Sagittal Canal Diameter change	This index was measured by CT, which was sagittal diameter of the spinal canal at the most compressed level.	pre-operation,3 months after surgery, 1 year after surgery