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

Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior 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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Spinal Cord Injury; Cervical Spinal Stenosis; Standardization; Individuation
• Intervention / Treatment: Procedure: Centerpiece titanium plate

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

Contacts and Locations

• Study Contact: Name: Wei Qi; Phone Number: +862984771012; Email: 14556263@qq.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Centerpiece titanium plate; All surgical operations were performed by the same group of senior spine surgeons. The range of open door decompression involved C3 ~ C7. For convenient operation and more accurate statistics, the right side of the door axis and the left side of the door seam were selected for all operations. Centerpiece titanium plates were used for intraoperative fixation.	Procedure: Centerpiece titanium plate; All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.
Experimental: 3D printed arch titanium plate; Before surgery, according to the imaging results, according to the effective imaging indicators screened in the early stage and the calculated door opening Angle formula, the door opening Angle of the patient's posterior cervical vertebra and the size of the fitted arch titanium plate were designed by mimics 10.0 software, and the titanium plate was printed using 3D printing technology. During the operation, the developed laminae opener was used to accurately control the door opening Angle and appropriate size titanium plate was installed for internal fixation. The standardized laminae door opening guide was used to complete the preparation of the door shaft side and door opening side of the lamina	Procedure: Centerpiece titanium plate; All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 6 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 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.	pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery
VAS score	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, 6 months after surgery, 1 year 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, 6 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, 6 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, 6 months after surgery, 1 year after surgery

Collaborators and Investigators

• Sponsor: Xijing Hospital

Publications and helpful links

General Publications

• 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.
• Schmeiser G, Bergmann JI, Papavero L, Kothe R. Surgical Treatment of Multilevel Degenerative Cervical Myelopathy: Open-Door Laminoplasty and Fixation via Unilateral Approach. A Feasibility Study. J Neurol Surg A Cent Eur Neurosurg. 2022 Sep;83(5):494-501. doi: 10.1055/s-0041-1739224. Epub 2021 Dec 15.
• Chen H, Liu H, Zou L, Li T, Gong Q, Song Y, Zeng J, Liu L, Kong Q. Effect of Mini-plate Fixation on Hinge Fracture and Bony Fusion in Unilateral Open-door Cervical Expansive Laminoplasty. Clin Spine Surg. 2016 Jul;29(6):E288-95. doi: 10.1097/BSD.0000000000000131.
• Yuan W, Zhu Y, Liu X, Zhu H, Zhou X, Zhou R, Cui C, Li J. Postoperative three-dimensional cervical range of motion and neurological outcomes in patients with cervical ossification of the posterior longitudinal ligament: Cervical laminoplasty versus laminectomy with fusion. Clin Neurol Neurosurg. 2015 Jul;134:17-23. doi: 10.1016/j.clineuro.2015.04.004. Epub 2015 Apr 17.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cervical spinal stenosis; open angle
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Trauma, Nervous System; Spinal Cord Diseases; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis; Spinal Cord Injuries
• Other Study ID Numbers: KY20222309-F-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