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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

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

Treatments: Procedure: Centerpiece titanium plate

Study type: Interventional

Funder types: Other

Identifiers

NCT05786313

KY20222309-F-1

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 28 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Centerpiece titanium plate

Active Comparator group

Description:

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.

Treatment:

Procedure: Centerpiece titanium plate

3D printed arch titanium plate

Experimental group

Description:

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

Treatment:

Procedure: Centerpiece titanium plate