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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Spinal Stenosis
• Intervention / Treatment: Procedure: cervical single open-door surgery

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanyan Jia; Phone Number: +862984771794; Email: xiyyllwyh@163.com

Study Locations

• China
  • Shannxi Province
    • Xi'an, Shannxi Province, China, 710034
      • Recruiting
      • Xijing Hospital
      • Contact: Wei Qi, Doctor; Phone Number: 15902984776; Email: 14556263@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lamina open angle	The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery	3 months after surgery
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: First Affiliated Hospital Xi'an Jiaotong University; Tang-Du Hospital; Xi'an Honghui Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Open angle; Cervical Spinal Stenosis; Cervical single open-door surgery
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis
• Other Study ID Numbers: KY20222157-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No