Diseases requiring spinal fusion
Conditions
Interventions
Experiment group:3D printing porous titanium alloy fusion cage
Control group:PEEK fusion cage
Sponsors
The third Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
23 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged between 18 and 75; 2. The soft tissue of the operation area meets the operation requirements; 3. Surgical treatment of single segment of the following diseases: spinal degeneration, traumatic instability; iatrogenic instability of spinal segment after intervertebral decompression; structural scoliosis; spinal canal stenosis, spinal deformity and other congenital diseases. 4. Those who did not participate in other clinical trials within 3 months; 5. Patients (or their legal representatives) volunteer to participate in clinical trials, read carefully and sign informed consent forms
Exclusion criteria
Exclusion criteria: 1. Obvious local or systemic severe infection; 2. Mental disorders or neuromuscular and vascular diseases that affect the effect of postoperative fixation; 3. Pregnant women of childbearing age (18-49 years old); 4. Patients whose surgical site is not covered by enough tissue; 5. Definite or suspected allergy to the metal material or foreign body used in the product; 6. Osteoporosis, osteomalacia or similar bone mineral density decreased significantly; 7. Systemic or metabolic diseases; 8. Serious heart and lung diseases: 9. Obesity may damage implants. 10. Patients are unwilling or unable to follow the instructions of postoperative treatment and / or rehabilitation programs; 11. Mental illness, substance abuse or alcohol abuse; there is no guarantee to quit smoking during fracture healing; 12. The existing bone mass is not enough to provide adequate support or fixation for the implant and affect bony fusion; 13. Spinal tumor, vertebral fracture; 14. Multiple spondylolisthesis, multi-stage spinal canal stenosis or intervertebral disc herniation need to be corrected by fusion; 15. The first operation failed and the revision or the second spinal fusion operation: 16. Those who are receiving radiotherapy: 17. Long-term use of drugs that affect bone and soft tissue healing (such as steroids, except methylprednisolone); 18. The use of growth factors or continuous use of sedative hypnotics and non-companion anti-inflammatory drugs for more than 3 months; 19. General health condition is poor, there are general anesthesia contraindications such as coronary heart disease and hypertension; 20. The researchers judged other conditions that were not suitable for selection (such as polio sequelae, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of interbody fusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of JOA score;Loss rate of intervertebral space height; | — |
Countries
CHINA
Contacts
Public ContactYONG SHEN
The third Hospital of Hebei Medical University
Outcome results
None listed