Thoracolumbar instrumentation
Conditions
Interventions
Unilateral assisted rod placement group:One side uses manual fixation rod placement, and the other side uses assisted fixation rod placement.
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Planned to undergo thoracolumbar multi-segment pedicle screw fixation with >=4 fixation segments; 2. Pedicle screw placement to be performed with the Tianji orthopedic surgical robot; 3. Aged 18 to 80 years; 4. American Society of Anesthesiologists (ASA) physical status classification Class I to III, with the ability to tolerate surgery; 5. Patients and their family members provide informed consent, voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. American Society of Anesthesiologists (ASA) physical status Class IV, with severe dysfunction of vital organs such as the heart, lungs, liver and kidneys, and inability to tolerate surgery. 2. Special spinal pathologies including spinal tumors, spinal infections, acute spinal trauma (< 72 hours post-injury), and congenital spinal malformations; coagulation disorders, immunodeficiency, and presence of surgical contraindications. 3. Psychiatric disorders or cognitive impairment, with inability to cooperate with follow-up. 4. Patients assessed as high surgical risk by the attending surgeon or anesthesiologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fixation rod installation time;lower back pain / lower limb pain and function score at 1 year postop; | — |
Secondary
| Measure | Time frame |
|---|---|
| 14-day infection rate;14-day instrument failure rate;Installation time of rod bending auxiliary system;Incidence of internal fixation-related complications at 1 year postoperatively;Incidence of delayed surgical site infection at 1 year postoperatively; | — |
Countries
China
Contacts
Public ContactXingye Li
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed