Osteoporotic vertebral compression fracture
Conditions
Interventions
Group 1:percutaneous vertebroplasty+acrylic resin bone cement (Type II)
Group 2:percutaneous vertebroplasty+polymethyl methacrylic bone cement
Sponsors
Guangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged 60-80 years male or female; 2. Osteoporotic vertebral compression fractures requiring percutaneous vertebroplasty, with imaging findings consistent with clinical symptoms; 3. Visual Analog Scale (VAS) score = 5.5 points; 4. Diagnosed as osteoporosis, T value = -2.5; 5. The target vertebral body for percutaneous vertebroplasty is =3; 6. Voluntarily participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with vertebral fractures or back pain caused by other lesions or who cannot be excluded from other lesions; 2) Patients with severe cardiopulmonary insufficiency or other functional diseases who cannot tolerate surgery; 3) Patients who take steroids for a long time; 4) Patients with a history of allergies to bone cement components; 5) In patients with liver and kidney dysfunction, liver function damage is defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 2 times the upper limit of normal value. Renal function damage is defined as upper limit of serum creatinine above normal. ; 6) Patients with extensive bone destruction at the posterior margin of the vertebral body and a large extent of incompleteness; 7) The degree of vertebral compression exceeds 75%, and patients without a puncture approach are expected; 8) Patients with coagulopathy and uncorrectable. 9) Women who are pregnant, breast-feeding, or unwilling to adopt appropriate methods of contraception during pregnancy or screening (appropriate contraceptive methods refer to sterilization, intrauterine devices, oral contraceptives or barrier contraception) and male patients with a birth plan during the trial; 10) Patients who participated in other clinical trials of drugs or medical devices within 30 days before screening; 11) The investigator believes that the subject is not eligible to participate in the study or the subject's compliance cannot complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale/Score(VAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry disability index;The vertebral body height; | — |
Countries
China
Contacts
Public ContactDongming Guo
Guangzhou First People's Hospital
Outcome results
None listed