Diseases requiring cervical fusion
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 years old; (2) Patients who need cervical fusion, cervical degeneration, cervical fracture, cervical tuberculosis, etc. (3) Subjects whose estimated survival time is greater than 6 months; (4) Voluntarily participate in the study and sign the informed consent form of the subject.
Exclusion criteria
Exclusion criteria: (1) Obese patients (BMI >=28.0kg / m2) that will cause the implant to fail to fix or the implant itself will be damaged due to overload; (2) Spinal tumors, including metastatic tumors; (3) Patients with cervical deformity; (4) Patients with a history of metal allergy; (5) Women during pregnancy or lactation; (6) Patients with obvious local or systemic severe infection, such as osteomyelitis; (7) Severe systemic diseases such as liver, kidney, brain, cardiovascular, respiratory and endocrine system, which cannot bear the operation; (8) Severe osteoporosis (T value =40 cigarettes per day; (12) Long-term use of drugs that affect bone and soft tissue healing (such as chemotherapy drugs, corticosteroids, except methylprednisolone) (for continuous use for more than 3 months); (13) Other conditions judged by the researcher as unsuitable for selection; (14) Subjects who participated in other clinical trials within 3 months before the start of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone graft fusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| JOA score and improvement rate;Height of anterior and posterior edge of fusion segment;VAS score; | — |
Countries
China
Contacts
The First Affiliated Hospital of University of South China