Suitable for filling and stabilization of vertebral body
Conditions
Interventions
control group:Using bone cement and injection tool mendec spine resin and kit produced by Tecres S.P.A
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) The subject or guardian is willing and able to sign the informed consent; 2) The age is 18-80 years (inclusive), and the gender is not limited; 3) Patients with indications of cemented vertebral filling operation; 4) Good compliance, willing and able to follow up as required.
Exclusion criteria
Exclusion criteria: 1) The posterior edge of vertebral body has extensive bone destruction, a large range of incomplete, and definite symptoms and signs of nerve injury; 2) Active infection was found in vertebrae or other parts of the body; 3) Vertebral compression fracture with a course of more than 12 months; 4) To treat the previous operation history of bone cement filling in vertebral body adjacent to vertebral body; 5) The number of vertebrae that need to be filled with bone cement at the same time = 3; 6) The degree of vertebral compression was more than 75%, and no puncture approach was expected; 7) Allergic to the components of bone cement; 8) Severe cardiopulmonary insufficiency or other chronic diseases can not tolerate surgery; 9) Patients with coagulation dysfunction and bleeding tendency; 10) Pregnant or lactating women; 11) Mentally incapacitated or unable to understand the requirements of participating in the study; 12) Patients who participated in other clinical studies within 1 month before the start of this study; 13) The researchers believe that subjects can not follow-up, which affects the scientific integrity of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of VAS pain relief 3 days ± 1 day after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry disability index score (ODI score);Recovery rate of vertebral height;Correction rate of Cobb angle in kyphosis; | — |
Countries
China
Contacts
Public ContactChangqing Zhang
Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai
Outcome results
None listed