Prospective Controlled Clinical Study of Individualized, Precise and Standardized Posterior Cervical Open-door Surgery for Cervical Spinal Stenosis
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 28
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Qi Wei
RECRUITING
Xi'an
Contact Information
Primary
Wei Qi
14556263@qq.com
+862984771012
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 500
Treatments
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.
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
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital