cervical spondylosis
Conditions
Interventions
Plate group:Use plate+cage for fusion
Zero-profile group:Using the zero-profile fusion device for fusion
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years old; (2) A patient with cervical spondylosis diagnosed based on clinical symptoms, signs, and imaging findings (satisfying any of the following criteria: prolapse of the nucleus pulposus; obvious osteophyte formation; loss of intervertebral height); (3) Those who have undergone standardized conservative treatment and become ineffective or have progressively worsened symptoms, affecting daily life and work, and require anterior decompression surgery; (4) The surgical segment is located between C3/4 and C6/7. (5) NDI score greater than or equal to 30%. (6) Be able to fully comply with this agreement psychologically and physiologically, and cooperate with the scheduled treatment plan, fill out forms, and follow up. (7) After the patient signs the informed consent, it means that the patient is aware of and agrees to carry out the relevant aspects of this study. The above inclusion standards are internationally recognized standards to ensure rationality and feasibility.
Exclusion criteria
Exclusion criteria: (1) Previous history of cervical spine surgery and adjacent segmental bone fusion. (2) Ossification of the posterior longitudinal ligament or stenosis of the cervical spinal canal, spinal fractures, severe osteoporosis, or a history of bone metabolic diseases. (3) Local infection and ulceration of neck skin, systemic inflammatory disease, uncontrolled diabetes, malignant tumor, active hepatitis, etc. (4) Individuals with mental illness or psychological disorders. (5) The overall condition is poor, and important organs suffer from serious diseases and cannot tolerate surgery. (6) Known to suffer from infectious diseases such as AIDS, syphilis, etc. (7) Suffering from autoimmune diseases. (8) I have received daily immunosuppressive therapy for over 1 month in the past 12 months. (9) Allergies to implant materials (PPE or titanium alloy) or experimental drugs. (10) Severe obesity, history of drug abuse. (11) Pregnancy planner during pregnancy or research period. (12) I am currently participating in other studies that may have an impact on the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cervical curvature;fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| JOA score;NDI score;VAS score;SF-36 score;Swallowing-Quality of Life, SWAL-QOL;Swallowing difficulty Bazaz score; | — |
Countries
China
Contacts
Public ContactHao Liu
West China Hospital, Sichuan University
Outcome results
None listed