Degenerative lumbar spine disease
Conditions
Interventions
Robotic Surgery Group (Mazor-X Spinal Surgery Robot-Assisted CBT Screw Placement):Before surgery, Mazor-X spine surgery robot planning software was used to plan the screw entry point and angle of the
Control group (manual placement of CBT screws):After successful anesthesia, the skin was incised, and the osseous structures of the surgical segment were exposed via a posterior midline approach to th
Sponsors
Shanghai First People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for osteoporosis; The diagnostic criteria for osteoporosis are mainly based on the comprehensive assessment of bone density measurement, history of fragility fractures, and clinical risk factors. Specifically: Based on bone density, the dual-energy X-ray absorptiometry (DXA) is currently the internationally recognized gold standard for diagnosis. For postmenopausal women and men aged 50 and above, the diagnostic criteria are as follows: Normal: T value >= -1.0; Osteopenia: -2.5 < T value < -1.0; Osteoporosis: T value <= -2.5; Severe osteoporosis: T value <= -2.5 and accompanied by fragility fractures. For children, premenopausal women, and men under 50 years old, the Z value is used for assessment. A Z value <= -2.0 indicates that the bone density is below the expected range for the same age group. Based on fragility fractures: If there are fragility fractures in the hip or vertebrae, regardless of bone density, it can be directly diagnosed as osteoporosis. If fragility fractures occur in the proximal humerus, pelvis, or distal forearm, and bone density measurement shows bone loss (-2.5 < T value < -1.0), it can also be diagnosed as osteoporosis. (2) Conservative treatment for 3 months was ineffective, including physical therapy and non-opioid drug treatment; (3) There is no history of other spinal surgeries; (4) There are no other significant functional impairments of vital organs, and the patient can tolerate the surgery.
Exclusion criteria
Exclusion criteria: Research participants who meet any of the following criteria are not eligible for inclusion in this study: (1) Severe coagulation disorders or currently taking anticoagulant medication; (2) Comatose or unable to perform any actions; (3) MRI contraindications (history of cardiovascular or cerebrovascular stent implantation, cardiac pacemaker, biological stimulator, etc.); (4) Uncontrolled severe infection or high fever; (5) Patients unable to cooperate with quality of life assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life ODI Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Number of intraoperative fluoroscopies;Surgery time;Blood loss;Blood routine test;Liver function;Kidney function;Coagulation function;Electrolyte;Erythrocyte Sedimentation Rate;C-reactive protein;Serological testing for infectious diseases;12-lead electrocardiogram;Echocardiography;Low back pain VAS score;Lower limb pain VAS score;Screw placement accuracy;Involvement of the superior articular process; | — |
Countries
China
Contacts
Public ContactSong Guo
Shanghai First People's Hospital
Outcome results
None listed