Diseases requiring spinal fusion
Conditions
Interventions
experiment group:Bone repair material + autogenous bone
control group:Allograft bone repair material + autogenous bone
Sponsors
The First Medical Center of the General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. between 18 and 75 years of age (including 18 and 75 years of age) and skeletally mature patients of any gender; 2. patients who, in the judgment of the investigator, require intervertebral implant fusion repair or vertebral body implant filling; 3. the site of spinal fusion is = bi-segmental (i.e. single or bi-segmental). 4. the patient voluntarily participates in the study and is willing to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. local or systemic overt or active infection at the surgical site; 2. those with a history of spinal surgery or severe osteoporosis who, in the judgment of the investigator, are not suitable for participation in this study 3. obese patients with a Body Mass Index (BMI) > 35 kg/m². 4. Patients with poorly controlled diabetes mellitus (fasting blood glucose = 8.0 mmol/L even after medication control). 5. Those without adequate soft tissue coverage at the surgical site 6. Severe heart, liver, kidney, lung, hematologic or metabolic diseases that cannot tolerate surgery 6. those with severe heart, liver, kidney, lung, hematologic or metabolic diseases that cannot tolerate surgery 7. previous or concurrent malignant tumors (cured malignant tumors with cancer-free survival of more than 5 years) Except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid cancer). 8. Received radiation therapy, chemotherapy, immunosuppression or systemic use of corticosteroids, or use of growth hormones within 6 months before the trial. Corticosteroids, growth factors, long-term use of sedative-hypnotics (continuous use for more than 3 months) (for more than 3 months), long-term use of non-steroidal anti-inflammatory drugs (for more than 3 months) Those who use non-steroidal anti-inflammatory drugs (for more than 3 months); 9. Known allergy to porcine-derived materials or collagen, or refusal to use porcine-derived medical products; 10. prediagnosed with Paget's disease, osteochondrosis or any other endocrine or metabolic bone disease affecting bone formation or metabolic bone disease affecting bone formation; 11. women during pregnancy or lactation; 12. have participated or are participating in a drug clinical trial within 3 months, or have participated or are participating in another medical device clinical trial within 30 days 12. those who have participated or are participating in a clinical trial of a drug within 3 months or have participated or are participating in a clinical trial of another medical device within 30 days 13. Other conditions that the investigator considers inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of interbody fusion; | — |
Countries
CHINA
Contacts
Public ContactZheng Wang
General Hospital of the Chinese people's Liberation Army
Outcome results
None listed