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

NCT05786313 | Recruiting

• 1 other identifier: KY20222309-F-1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Spinal Stenosis; Cervical Spinal Cord Injury; Individuation; Standardization

Keywords

cervical spinal stenosis; open angle

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Maximum spinal cord compression change

  pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery

• Compression ratio change

  pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery

• Transverse area change

  pre-operation,3 months after surgery, 6 months after surgery, 1 year after surgery

Study Arms (2)

Centerpiece titanium plate

ACTIVE COMPARATOR

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

3D printed arch titanium plate

EXPERIMENTAL

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

Interventions

Centerpiece titanium plate PROCEDURE

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

3D printed arch titanium plate; Centerpiece titanium plate

Eligibility Criteria

• Age: 28 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Qi Wei

Xi'an, Shannxi Province, 710034, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 34911089 BACKGROUND

• 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.

  PMID: 26338009 BACKGROUND

• 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.

  PMID: 25023712 BACKGROUND

• 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.

  PMID: 25929463 BACKGROUND

Central Study Contacts

Wei Qi

CONTACT

+862984771012; 14556263@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 27, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)