Suitable for filling and stabilization of vertebral body
Conditions
Interventions
Control group:Mendec Spine Resin and Kit made by Tecres S.P.A were used
Sponsors
The Third Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Between 18 and 80 years of age, regardless of gender; 2. Obvious pain caused by vertebral compression fracture, vertebral tumor, or symptomatic vertebral hemangioma, requiring percutaneous vertebroplasty; 3. The number of vertebral bodies in the lesion is less than or equal to 2, and they are not adjacent to each other; 4. The subject or his/her legal representative can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The diseased vertebra has received previous surgical treatment; 2. Patients with vertebral tuberculosis or spinal cord and/or nerve root injury, spinal stenosis requiring surgical treatment, systemic infection or uncontrolled local infection, severe soft tissue injury at the site of operation or failure of other vital organs; 3. The diseased vertebrae should be treated with other surgical treatments besides percutaneous vertebroplasty; 4. Intervertebral disc herniation adjacent to the diseased vertebral body requires surgical treatment; 5. There were pedicle fractures or extensive damage to the posterior wall of the vertebral body, incomplete in a large range, and damage to the posterior ligament complex in the diseased vertebrae; 6. Severe compression fractures (thoracic vertebral compression rate >=50% or lumbar vertebral compression rate >=75%); 7. History of allergy to implants; 8. Severe coagulation disorder (PT or APTT > 2 times the upper limit of normal value); 9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 2 times of the normal upper limit; 10. Serum creatinine (Cr) was greater than 2mg/ dL (177umol/L); 11. Pregnant or lactating women; 12. Participated in other interventional clinical trials within 3 months prior to enrollment; 13. For the benefit of the subject, the investigator considers that the subject should not participate in other situations of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate was 3 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recovery rate of vertebral height;Cobb Angle correction rate;Oswestry disability index improvement rate;Vertebra height loss rate;Evaluation of device operation performance; | — |
Countries
China
Contacts
Public ContactWei Chen
Third Hospital of Hebei Medical University
Outcome results
None listed