cervical spondylosis
Conditions
Interventions
lower cervical artificial joint replacement group:treated with lower cervical artificial joint replacement
anterior cervical corpectomy and fusion group:treated with anterior cervical corpectomy and fusion
Sponsors
Xi'an International Medical Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 years; (2) For inferior cervical artificial disc replacement, patients with cervical spondylosis who are planned to undergo anterior cervical corpectomy and resection of two adjacent intervertebral discs; (3) For anterior cervical corpectomy and fusion, patients with cervical spondylosis who are planned to undergo anterior cervical corpectomy and resection of two adjacent intervertebral discs; (4) Sign an informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who have participated in other clinical studies 3 months before the inception of the study; (2) Abnormalities in liver and kidney functions (aspartate aminotransferase, alanine aminotransferase, blood creatinine and urea nitrogen levels are 1.5 times higher than normal); (3) Obvious abnormalities in the blood system; (4) Abuse of drugs or ethanol; (5) Patients who have brain disorders, abnormal judging ability, or cannot cooperate with the observer; (6) Coronary heart disease or severe kidney disease; (7) Severe metabolic diseases and endocrine diseases that are out of drug control; (8) Pregnant and lactating women and couples who are about to become pregnant in the near future; (9) Severe lung diseases such as asthma and lung dysfunction; (10) Immunodeficiency; (11) Single-segment intervertebral disc herniation or compression; (12) 3 or more vertebral segments herniated or spinal cord compression due to ligament ossification; (13) Active infection (systemic or local cervical spine) or a history of local cervical spine infection; (14) A history of anterior cervical surgery; (15) Patients with a need for posterior surgical treatments, with severe arthritis of the cervical spine joint process, and with spinal cord compression on the back; (16) Severe osteoporosis; (17) Cervical vertebra deformity; (18) A history of ossification of the posterior longitudinal ligament of the cervical spine, ankylosing spondylitis, and heterotopic ossification; (19) Severe cervical spine instability or trauma to the posterior structure of the cervical spine, and cervical spondylolisthesis; (20) Abnormal soft tissues anterior to the cervical spine (tracheal or esophageal malformations, and a history of radiotherapy), and obesity; (21) Allergy to prosthetic materials; (22) Patients who have tumors that cannot be completely resected and patients who are predicted to suffer prosthetic loosening during survival time; (23) Other contraindications for surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cervical joint range of motion at 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cervical fusion rate at 3 and 6 months after operation;Cervical joint range of motion at 7 days and 3 months after operation;Japanese Orthopaedic Association (JOA) scores at 7 days, 3 months and 6 months after operation;Neck Disability Index (NDI) scores at 7 days, 3 months, and 6 months after operation;Visual analogue scale (VAS) scores at 7 days, 3 months, and 6 months after operation;CT images of the cervical spine at 7 days postoperatively;X-ray of the cervical spine at 7 days, 3 months and 6 months after operation; | — |
Countries
China
Contacts
Public ContactXijing He
Xi'an International Medical Center Hospital
Outcome results
None listed