Spinal diseases
Conditions
Interventions
Experimental Group:Spinal fusion surgery with bone repair material produced by Zhejiang Disai Biotechnology Co., Ltd.
Control group:Spinal fusion surgery with artificial bone repair material produced by Allgens Medical Technology Co., Ltd.
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age >=18 and <=75 years old, regardless of gender; 2) Spinal fusion surgery is required due to cervical, thoracic, lumbar degenerative lesions, disc herniation, spinal stenosis, spondylolisthesis, pseudoarthrosis, spinal instability, spinal deformity, spinal trauma, etc.; 3) The target fusion segment range is C2~S1, and the target fusion segment is <=2; 4) The subject or his legal representative can understand the purpose of the study, show sufficient compliance with the study plan, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) BMI>35kg/m^2; 2) Previous spinal fusion surgery failed or adjacent vertebrae disease occurred and required revision; 3) Severe osteoporosis, determined by the researchers to be unable to undergo surgery; 4) Combined with systemic infection or uncontrolled local infection, severe soft tissue injury or insufficient soft tissue coverage at the planned surgical site, severe vascular or severe nerve injury, malignant tumor, confirmed severe malnutrition or other important organ failure; 5) Combined with diseases that may affect bone metabolism or spinal fusion (such as Paget's disease, rheumatoid arthritis, osteogenesis imperfecta, etc.); 6) Oral or injection of sedatives and hypnotics every week within 3 months before screening; 7) Received chemotherapy drugs or radiotherapy within 6 months before screening or during the screening period; 8) Cumulative oral or injection of corticosteroids or various growth factors for >=14 days within 1 month before screening or during the screening period; 9) History of allergy to porcine materials or collagen, or refusal to use porcine medical products; 10) Pregnant or lactating women; 11) Patients with severe heart, lung, liver, kidney, blood system or metabolic diseases who cannot tolerate surgery; 12) Participated in other clinical trials that may affect this trial within 3 months before screening; 13) Other situations where the researcher believes that the subject should not participate in this clinical trial for the benefit of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spinal fusion rate 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative spinal stability;JOA score improvement rate;Postoperative intervertebral disc height loss level;SF-36 scale score;Equipment operation satisfaction evaluation;Equipment defect rate;Adverse event rate; | — |
Countries
China
Contacts
Public ContactWang Qiang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed