Pedicle Screw Fixation of Spine
Conditions
Brief summary
This clinical trial is a prospective, multicenter, non inferiority, randomized controlled trial. We plan to include 112 subjects in China and randomly assign them to the experimental group and the control group according to the ratio of 1:1. The experimental group used the orthopedic surgery navigation and positioning system produced by Nanjing Tuodao Medical Technology Co., Ltd., while the control group used the orthopedic surgery navigation and positioning system produced by Beijing tianzhihang Medical Technology Co., Ltd. Taking the position deviation of Kirschner wire as the main evaluation index, it was proved that the test instrument was not inferior to the control instrument. The test data shall be submitted to the State Drug Administration for approval of the marketing license of the test device
Interventions
DEVICENavigation and Positioning System for Orthopedic Surgeries
Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation
Sponsors
Nanjing Tuodao Medical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
NS100
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. They were 18-75 years old; 2. From thoracic vertebrae to lumbar vertebrae, pedicle screw fixation is needed; 3. Signed informed consent, willing to receive treatment and follow-up according to the requirements of the trial protocol.
Exclusion criteria
1. Patients with pedicle deformity. 2. Patients with severe osteoporosis. 3. Patients with spinal tumor or tuberculosis. 4. Patients with abnormal liver function (alanine aminotransferase, aspartate aminotransferase values \> 3 times of the upper limit of the normal range) and abnormal renal function (creatinine values \> 3 times of the upper limit of the normal range). 5. Patients with abnormal coagulation function (prothrombin time, activated partial thromboplastin time \> 1.5 times of the upper limit of normal range). 6. Pregnant or lactating women. 7. Patients with mental disorders. 8. The investigators evaluated patients who were not suitable for pedicle screw fixation. 9. Patients who are participating in clinical trials of any other device or drug. 10. Poor compliance, difficult to cooperate with patients who complete treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deviation of the position of Kirschner needle | Immediately after operation | Comparing the actual placement position of Kirschner wire with the planned position of C-arm 3D scanning, the average deviation of the entry point and the insertion point was the position deviation of Kirschner wire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Entry point deviation | Immediately after operation | The space distance between the entrance point of the planned position of the passage and the axis of the actual placement position of the Kirschner wire |
| Dead center deviation | Immediately after operation | The space distance between the end point of the planned position of the passage and the axis of the actual placement position of the Kirschner wire |
| Angle deviation of axial plane | Immediately after operation | The minimum angle between the planned position of the passage and the projection position of the Kirschner wire on the axial plane |
| Angular deviation of sagittal plane | Immediately after operation | The minimum angle between the planned position of the passage and the projection position of the Kirschner wire on the sagittal plane |
| Spatial angle deviation | Immediately after operation | The minimum angle between the planned position of the passage and the actual position of the Kirschner wire in space |
| Operation time | Immediately after operation | The time from the beginning of registration to the end of the nail placement in the navigation and positioning system of orthopedic surgery |
| Incidence of re nailing | Immediately after operation | — |
| Excellent and good rate of pedicle screw placement | Discharge or 7 days after surgery, whichever comes first | Gertzbein Robbins classification criteria: whether there is cortical penetration in the lateral, medial, cephalic and caudal directions of pedicle screws (A: no cortical invasion; B: no cortical invasion); B: Cortical penetration was less than 2 mm; C: 2mm ≤ cortical penetration \< 4mm; D: 4mm ≤ 6 mm; E: Cortical penetration ≥ 6 mm) |
| apparatus Success rate | Immediately after operation | Instrument success refers to that during the operation, the operator completes the operation channel planning based on the three-dimensional scanning image data of the C-arm, and the orthopedic surgery navigation and positioning system makes the manipulator move to the position specified in the operation planning under the monitoring of the operator, without instrument defects |
| Technical success rate | Immediately after operation | Technical success refers to the successful insertion of Kirschner wire along the guider and sleeve during the operation without re insertion or changing to manual insertion |
| Success rate of operation | Immediately after operation | The success of operation refers to the success of instruments and techniques in the operation without serious complications |
| Incidence of device defects | Immediately after operation | Device defect refers to the unreasonable risk of medical devices that may endanger human health and life safety in normal use, such as label error, quality problem, fault, etc |
| Incidence of severe surgical complications | Discharge or 7 days after surgery, whichever comes first | Severe complications included nerve root injury, vascular injury, spinal cord injury, visceral injury and pedicle fracture |
| Incidence of adverse events and serious adverse events | Discharge or 7 days after surgery, whichever comes first | — |
| Incidence of conversion to manual nail placement | Immediately after operation | — |
Contacts
Primary ContactJing Pan
Outcome results
None listed