Intervertebral disc degeneration
Conditions
Interventions
Group treated with 3D-printed porous titanium alloy intervertebral fusion device coated with hydroxyapatite (HA) layer
:Types of intervertebral fusion devices
Company: Dimension (Xi'an) Biomedical Technology Co., Ltd.
Material: Titanium alloy (TC4)/hydroxyapatite
Product Name: Hydroxyapatite-coated porous titanium all
Group treated with traditional PEEK fusion device:Interbody fusion is performed with a conventional PEEK fester.
Sponsors
The Second Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The subjects' ages range from 50 to 85 years old (inclusive of 50 years old and 85 years old), and gender is not restricted. 2. Subjects with spinal degenerative diseases such as intervertebral disc protrusion, spinal canal stenosis and/or instability of vertebral segments due to intervertebral disc degeneration, who need to undergo intervertebral fusion and internal fixation surgery. 3. Subjects whose dual-energy X-ray absorptiometry examination within 1 month indicates decreased bone mass (-2.5 <T<=-1) and osteoporosis (T<=-2.5). 4. Subjects who have not responded to conservative treatment for 4 weeks (except for emergency patients whose researchers consider to meet the surgical indications). 5. Subjects who have not participated in other clinical trials within 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients who are mentally incapable or unable to understand the requirements of participating in the research, such as those who cannot express, read or understand the questions in the subject's self-report questionnaire stipulated in the research protocol, and who cannot provide feedback information in an appropriate language; 2. Patients with any internal or external diseases that may affect the benefits of spinal implant surgery, such as those with severe metabolic system diseases, immune system diseases, hematological system diseases and a history of malignant tumors, etc.; 3. Those with serious diseases of important organs such as heart, liver, lung and kidney (judged by the investigator); 4. Patients with significantly abnormal body temperature, erythrocyte sedimentation rate, and white blood cell count who cannot clearly identify the cause (judged by the investigator); 5. Those with insufficient soft tissue coverage at the surgical site; 6. Patients with increased bone brittleness due to congenital or acquired factors, or those with severe calcification disorders; 7. Those with infection involving the surgical site or local inflammatory manifestations; 8. Patients with pathological obesity (Body Mass Index [BMI] >= 40); 9. Patients with aggressive joint diseases, osteomalacia, bone resorption and severe osteoporosis (T < -3.5); 10. Patients suspected or confirmed to be allergic or intolerant to foreign bodies (metal materials); 11. Patients with intervertebral segments that have undergone fusion surgery in the past; 12. Patients who have been taking drugs that affect bone and soft tissue healing for a long time (such as chemotherapy drugs, corticosteroid hormones, etc.); 13. Patients undergoing radiotherapy; 14. Patients using growth factors or taking sedative-hypnotic drugs or non-steroidal anti-inflammatory drugs for more than 3 consecutive months; 15. Other situations judged by the investigator as not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of intervertebral fusion 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of intervertebral fusion 6 months after surgery;Postoperative cage subsidence rates at 6 and 12 months;Postoperative 1-, 3-, 6-, and 12-month JOA/ODI indices, HRQoL (RAND-36) self-measurement scores;Incidence of revision surgery;Postoperative complications;Adverse events; | — |
Countries
China
Contacts
Public ContactLi Xiaoxiang
The Second Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed