Lumbar Degenerative Disease, Lumbar Disc Herniation, Lumbar Spinal Stenosis
Conditions
Interventions
Control group:Undergo conventional spinal fusion surgery
Experimental group:Accept bone glue produced by Hangzhou Yuannang Biotechnology Co., Ltd. for spinal fusion surgery by bonding the interbody fusion device
Sponsors
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old and <=75 years old, regardless of gender; 2. Spinal fusion surgery is required due to lumbar degenerative diseases, lumbar disc herniation, lumbar spinal stenosis, etc.; 3. The range of target fusion segments is L2~S1, and the target fusion segment is 1. 4. Meyerding grade of target fusion segment<=grade I; 5. Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.BMI>35kg/m^2; 2. Lateral slippage in the target segment; 3. Previous spinal fusion surgery failed or proximal spondylosis required revision; 4. Severe osteoporosis, which cannot be operated on by the investigator; 5. Combined with systemic infection or uncontrolled local infection, severe soft tissue injury or insufficient soft tissue coverage at the proposed surgery, severe vascular or severe nerve damage, malignant tumor, diagnosed severe malnutrition or other important organ failure; 6. Combined diseases that may affect bone metabolism or spinal fusion (such as Paget's disease, rheumatoid arthritis, osteogenesis imperfecta, etc.); 7. Oral or weekly sedative hypnotic drugs within 3 months before screening; 8. Received chemotherapy drugs or radiotherapy within 6 months before screening or during the screening period; 9. Cumulative oral or injected corticosteroids or various growth factors within 1 month or during the screening period >=14 days; 10. Pregnant or lactating women; 11. Combined with severe heart, lung, liver, kidney, hematological system or metabolic diseases that cannot tolerate surgery; 12. Participated in other clinical trials that may affect this trial within 3 months before screening; 13. Other situations in which the investigator believes that he should not participate in this clinical trial for the benefit of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SF-36 scale score;Operation time;Evaluation of equipment operation performance;Spinal fusion rate at 6 months postoperatively.;Interbody fusion device displacement;JOA score improvement rate;Surgical bleeding;Spinal stability at 3 to 6 months after surgery;Level of intervertebral space height loss at 3 months and 6 months postoperatively.;Incidence of interbody fusion displacement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of device defects;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactXiangqian Fang
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Outcome results
None listed