A Prospective, Multicenter, Non Inferiority, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Pedicle Screw Fixation Assisted by Orthopedic Surgical Navigation System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pedicle Screw Fixation of Spine
- Sponsor
- Nanjing Tuodao Medical Technology Co., Ltd
- Enrollment
- 112
- Primary Endpoint
- Deviation of the position of Kirschner needle
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •They were 18-75 years old;
- •From thoracic vertebrae to lumbar vertebrae, pedicle screw fixation is needed;
- •Signed informed consent, willing to receive treatment and follow-up according to the requirements of the trial protocol.
Exclusion Criteria
- •Patients with pedicle deformity.
- •Patients with severe osteoporosis.
- •Patients with spinal tumor or tuberculosis.
- •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).
- •Patients with abnormal coagulation function (prothrombin time, activated partial thromboplastin time \> 1.5 times of the upper limit of normal range).
- •Pregnant or lactating women.
- •Patients with mental disorders.
- •The investigators evaluated patients who were not suitable for pedicle screw fixation.
- •Patients who are participating in clinical trials of any other device or drug.
- •Poor compliance, difficult to cooperate with patients who complete treatment and follow-up.
Outcomes
Primary Outcomes
Deviation of the position of Kirschner needle
Time Frame: 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 Outcomes
- Entry point deviation(Immediately after operation)
- Dead center deviation(Immediately after operation)
- Operation time(Immediately after operation)
- apparatus Success rate(Immediately after operation)
- Incidence of device defects(Immediately after operation)
- Angle deviation of axial plane(Immediately after operation)
- Technical success rate(Immediately after operation)
- Excellent and good rate of pedicle screw placement(Discharge or 7 days after surgery, whichever comes first)
- Angular deviation of sagittal plane(Immediately after operation)
- Incidence of re nailing(Immediately after operation)
- Incidence of severe surgical complications(Discharge or 7 days after surgery, whichever comes first)
- Incidence of adverse events and serious adverse events(Discharge or 7 days after surgery, whichever comes first)
- Spatial angle deviation(Immediately after operation)
- Incidence of conversion to manual nail placement(Immediately after operation)
- Success rate of operation(Immediately after operation)