Vertebral tumor/vertebral tuberculosis/vertebral instability, burst fracture
Conditions
Interventions
Single-arm study:Implant the 3D-printed customized artificial vertebral body into the subjects who meet the enrollment criteria.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients should be aged between 18 and 80 years old (including 18 and 80 years old), and there is no gender limitation. 2.Those who need to undergo spinal stability reconstruction due to spinal instability. 3.Those who have not participated in other clinical trials within three months. 4.Fully understand the benefits and risks of customized medical devices, still be willing to participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who have already suffered from severe organ damage. 2.Patients with mental diseases. 3.Pregnant women and women during the lactation period. 4.Patients with congenital or acquired increased bone fragility, or those with severe problems of hypocalcification. 5.Patients who are suspected of or have been confirmed to be allergic or intolerant to metal materials. 6.Pediatric patients whose skeletal development has not yet matured. 7.Patients with infections involving the surgical site (except spinal tuberculosis). 8.Other patients considered inappropriate by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The fusion stability of the artificial vertebral body.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement rate of the Japanese Orthopaedic Association (JOA) functional score.;The height between vertebral bodies.; | — |
Countries
China
Contacts
Public ContactSun Wei
Shanghai General Hospital
Outcome results
None listed