Cervical, thoracic, lumbar degenerative diseases, disc protrusion, spinal stenosis, spondylolisthesis, pseudarthrosis and spinal instability, and lesions, spinal deformity requiring spinal segmental f
Conditions
Interventions
Experimental group:Spinal interbody fusion cage developed by Tianjin Zhengtian Medical Instrument Co., Ltd.
Control group:Spinal interbody fusion cage manufactured by Medtronic Sofamor Danek USA, Inc.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects or their guardian are willing and able to sign the informed consent before the surgery; 2. Aged 18-75 years old male and female; 3. The subjects who have diseases involving the cervical spine (C2-T1) or thoracic lumbar sacral vertebra (T10-L5/S1), and have at least 4-6 weeks unsuccessful non-surgical conservative treatment, thus need the spinal fusion treatment; 4. The subjects without contraindications in the preoperative routine tests and examinations; 5. The subjects who have good compliance, are willing and able to perform the follow-up as required.
Exclusion criteria
Exclusion criteria: 1. Obvious severe local or systemic infection, such as osteomyelitis; 2. Any mental or neuromuscular and vascular diseases which may result in the risks of unacceptable fixed failure or complications during the postoperative care; 3. Pregnancy; 4. The subjects without enough soft tissue coverage at the operative sites; 5. Obvious or suspected allergies to metal, polymer or foreign body; 6. Osteoporosis, osteomalacia or similar bone density decrease is the relative contraindication to surgery, because it may decrease the achieved correction degree and/or mechanical fixation effect, especially for the elderly patients with severe osteoporosis, except for the subjects who have been evaluated by the surgeons that is not adequately affect the safety and effectiveness of the operation; 7. Systemic or metabolic disease, except for the subjects whose hypertension, diabetes and other can be controlled within the clinically acceptable range; 8. The subjects with poor overall health, for example, the subjects with conventional general anesthesia contraindications such as coronary heart disease and hypertension, who have been evaluated to be not suitable for the operation by the anesthesiologist; 9. Obesity that can lead to the implant fixation failure, or implant damage due to excessive load; 10. The subjects who are unwilling or unable to follow the instructions of the postoperative therapy and/or rehabilitation plan; 11. Mental disease, drug abuse or alcohol abuse; the subjects who cannot guarantee to quit smoking during fracture healing; 12. The existing bone mass which has been affected due to the disease, infection or previous surgical procedure, makes it impossible to provide enough support and/or fixation for the implant, and affect the bone fusion; 13. Spinal tumors, including metastases; the subjects who are undergoing radiation therapy; 14. Long-term use of drugs that affect the healing of bone and soft tissues (such as chemotherapy drugs, corticosteroids, except for methylprednisolone); use of growth factors, long-term use of sedative hypnotics (continuous use for more than 3 months), long-term use of non-steroidal anti-inflammatory drugs (continuous use for more than 3 months); 15. Other conditions which are not suitable for inclusion judged by the investigator (such as the sequelae of polio, etc., which affect the normal implantation of interbody fusion cages); 16. The subjects who are mentally incompetent or unable to understand the requirements for participation in the study; 17. Expected non-compliance; 18. Skeletal immature, developing patient; 19. The subjects who have other comorbidities which limit their participation in the study, and cannot follow up or affect the scientific integrity of the study; 20. The subjects who refuse to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiography; | — |
Secondary
| Measure | Time frame |
|---|---|
| JOA cervical score;Neck Disabilitv Index;JOA Back Pain Evaluation Questionnaire;Oswestry Dability Index;SF-12 score;ODOM scale;VAS score; | — |
Countries
China
Contacts
Public ContactSong Yueming
West China Hospital, Sichuan University
Outcome results
None listed