spinal disease
Conditions
Interventions
test group:Application of the artificial vertebral body
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70 years, regardless of gender; 2. It meets the diagnostic criteria and has the indication of operation; It is proposed to use artificial vertebral body to reconstruct internal fixation after vertebra resection; 3. Patients who read the informed consent form in detail, fully understood this clinical trial, volunteered to participate in the trial and signed the informed consent form; 4. No contraindications to surgery; 5. 18 <= BMI <= 30.
Exclusion criteria
Exclusion criteria: 1. Acute suppurative infection; 2. Patients and their guardians cannot understand the requirements of participating in the study; 3. Other diseases associated with the subjects restrict their participation in the study and cannot follow up or affect the scientific integrity of the study; 4. Definite or suspected allergy to the metal used in the product; 5. Pregnant and lactating women; 6. Patient non-compliance is expected; 7. Patients who have participated in clinical trials of other drugs, biological agents or medical devices before signing knowledge have not reached the time limit for the end point of the study; 8. Untreated or unable to improve blood coagulation dysfunction; 9. Patients with severe liver and renal dysfunction (glutamic pyruvic transaminase ALT and / or aspartate oxaloacetic transaminase AST >= 2 times the normal upper limit; serum creatinine and urea nitrogen >= 2 times the normal upper limit). 10. The patient meets the contraindication of the product. 11. Patients with bone destruction of upper and lower vertebrae at the site of vertebral resection and reconstruction; 12. Patients with severe osteoporosis (bone mineral density T <= -2.5 + brittle fracture). 13. The researchers judged other situations that were not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interbody fusion rate;Adverse events;Instrument defect; | — |
Secondary
| Measure | Time frame |
|---|---|
| Japanese Orthopaedic Association Scores;Visual Analogue Scale score;Imaging evaluation; | — |
Countries
China
Contacts
Public ContactJianru Xiao
Shanghai Changzheng Hospital
Outcome results
None listed