Cervical and Thoracolumbar Interbody Fusion Surgery
Conditions
Interventions
Experimental group :The experimental group adopts additively manufactured titanium alloy interbody fusion cages
Control group:Tthe control group uses PEEK interbody fusion cages manufactured by the same manufacturer.
Sponsors
The Third Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years (inclusive of 18 and 75 years), gender not limited; 2. Lumbar disc herniation and/or vertebral segment instability caused by intervertebral disc degeneration, requiring interbody fusion surgery; 3. Cervical spine (C2/3–C7/T1) or thoracolumbar spine (T1/2–L5/S1), with one or two segments requiring interbody fusion; 4. Ineffective after at least 4 weeks of non-surgical conservative treatment (except for patients considered emergencies meeting surgical indications by the investigator); 5. Voluntarily willing to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of obvious local or systemic severe infection; 2. Presence of any mental, neuromuscular, or vascular disease that may result in unacceptable fixation failure or complications during postoperative care; 3. Severe primary diseases involving the heart, brain, liver (AST/ALT > 3 times the upper limit of normal), kidneys (Scr > 1.5 times the upper limit of normal), hematopoietic system, endocrine system, etc., or overall poor health, including routine contraindications to general anesthesia such as coronary heart disease or hypertension, and judged by the investigator as unsuitable for the study; 4. Insufficient soft tissue coverage at the surgical site; 5. Presence of osteoporosis, osteomalacia, or similar bone density reduction, spinal tumors (including metastases), spinal fractures, and judged by the investigator as unsuitable for participation; 6. Obesity (BMI >=30 kg/m²) that may lead to fixation failure or implant damage due to excessive load; 7. Existing bone quantity affected by disease, infection, or previous surgery, rendering it insufficient to support and/or fix the implant and affecting bone fusion; 8. History of peripheral vascular disease, metabolic disease, chronic alcoholism, or drug abuse; 9. Inability to guarantee smoking cessation during fracture healing; 10. Long-term use of drugs affecting bone or soft tissue healing (e.g., chemotherapeutic drugs, corticosteroids except methylprednisolone); 11. Use of growth factors or continuous use of sedative-hypnotic drugs or non-steroidal anti-inflammatory drugs for more than 3 months; 12. Skeletally immature individuals still in development; 13. Known or suspected allergy to the product material or foreign substances; 14. Currently undergoing radiotherapy; 15. Pregnant or breastfeeding, or planning pregnancy during the study; 16. Participation in another clinical trial within the past 3 months; 17. Investigator judgment deeming the candidate unsuitable for inclusion (e.g., sequelae of poliomyelitis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fusion efficiency;Japanese Orthopaedic Association Scores;Visual Analogue Scale;Intervertebral disc height; | — |
Countries
China
Contacts
Public ContactDi Zhang
The Third Hospital of Hebei Medical University
Outcome results
None listed