Lumbar Kummell disease
Conditions
Interventions
Experiment group:Mazor spinal robot-assisted unilateral modified approach percutaneous vertebroplasty
Control group:Bilateral percutaneous vertebroplasty with free hand
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of osteoporosis; 2. Aged >= 60 years, with obvious symptoms of low back pain and limited activity; 3. lumbar compression fracture of a single vertebral body; 4. Imaging suggested that there were depressions or transverse light transmittance changes in the vertebral body, and characteristic vacuum fissure sign (IVC) appeared in the vertebral body; 5. Imaging suggested stage I and II Kummell's disease without neurological symptoms of lower limbs; 6. Imaging showed that the posterior wall of the vertebral body was intact, and no fracture block invaded the spinal canal; 7. No fractures in other parts or dysfunction of important organs, and can tolerate surgery.
Exclusion criteria
Exclusion criteria: 1. Kummell's disease with neurological symptoms; 2. Preoperative X-ray examination showed that the vertebral compression degree of fracture was > 75%; 3. Severe deformity of local kyphosis (Cobb's Angle >= 40 degree); 4. Patients suspected of having primary or metastatic vertebral lesions, multiple myeloma and metabolic bone disease; 5. Chronic thoracolumbar and back pain caused by spinal degenerative diseases; 6. Vertebral fractures in other parts occurred during follow-up; 7. Patients with severe cardiopulmonary insufficiency and severe coagulation disorders have a history of drug abuse or are taking anticoagulants orally; 8. Unconscious or incapacitated persons; 9. MRI contraindications (cardio-cerebrovascular stent implantation history, pacemaker, biological stimulator, etc.); 10. Uncontrolled severe infection or high fever; 11. allergic to bone cement; 12. Vertebral fractures in other parts occurred during follow-up; 13. Previous vertebral augmentation and other spinal operations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cobb angle; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs (body temperature, pulse, respiration, blood pressure) and body weight;Bone cement leakage rate;Number of intraoperative fluoroscopy;Operation time;Blood loss;Blood RT;urine RT;Microscopic examination of urine sediment;Liver function;renal function;Blood coagulation function;Electrolyte;Inflammatory indicators;Serological indicators of infectious diseases;Serum tumor markers;ECG;cardiac ultrasonic;Vertebral height value;Wedge Angle of vertebral body;ODI (Oswestry disability index) score for quality of life;VAS score of low back pain;hospital stays; | — |
Countries
China
Contacts
Public ContactGuo Song
Shanghai General Hospital
Outcome results
None listed