Spinal tumors, spinal tuberculosis, trauma, and other disorders
Conditions
Interventions
Combined Fixation Group:Artificial Vertebral Body Assisted Fixation + Posterior Pedicle Screw-Rod Fixation
Single Fixation Group:Artificial Vertebral Body + Simple Posterior Pedicle Screw-Rod Fixation Group
Sponsors
Shanghai JiaoTong university Affiliated Sixth People‘s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 80 years inclusive, with no gender restrictions; 2. Patients requiring reconstruction involving resection of two or more segments of the thoracolumbar spine due to factors such as tumours, trauma, or vertebral tuberculosis; 3. Patients who voluntarily participate and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Active systemic or localised infection (excluding tuberculosis) that is not effectively controlled; 2. Presence of systemic disease rendering the subject unable to tolerate anaesthesia or surgery, including coagulation disorders, severe cardiac disease, or severe respiratory disease; 3. Confirmed allergy or intolerance to metallic materials; 4. Psychiatric disorders rendering the subject mentally incapable or unable to comprehend study requirements, or demonstrating significant non-compliance; 5. Positive pregnancy test; 6. Participation in any other clinical trial within the three months preceding enrolment; 7. Other circumstances deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interface Fusion Rate at 12 Months Postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| JOA Functional Score;SF-12 Score;VAS Pain Score;Prosthetic Subsidence;Safety Indicators; | — |
Countries
China
Contacts
Public ContactMa xin
Shanghai JiaoTong university Affiliated Sixth People‘s Hospital
Outcome results
None listed