Navigation and Positioning System for Orthopedic Surgery

Nanjing Tuodao Medical Technology Co., Ltd112 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Pedicle Screw Fixation of Spine

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Deviation of the position of Kirschner needle

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

Time frame: Immediately after operation

Secondary Outcomes

Excellent and good rate of pedicle screw placement

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)

Time frame: Discharge or 7 days after surgery, whichever comes first

Entry point deviation

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

Time frame: Immediately after operation

Dead center deviation

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

Time frame: Immediately after operation

Angle deviation of axial plane

The minimum angle between the planned position of the passage and the projection position of the Kirschner wire on the axial plane

Time frame: Immediately after operation

Angular deviation of sagittal plane

The minimum angle between the planned position of the passage and the projection position of the Kirschner wire on the sagittal plane

Time frame: Immediately after operation

Spatial angle deviation

The minimum angle between the planned position of the passage and the actual position of the Kirschner wire in space

Time frame: Immediately after operation

Operation time

The time from the beginning of registration to the end of the nail placement in the navigation and positioning system of orthopedic surgery

Time frame: Immediately after operation

Incidence of re nailing

Time frame: Immediately after operation

Incidence of conversion to manual nail placement

Time frame: Immediately after operation

apparatus Success rate

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

Time frame: Immediately after operation

Technical success rate

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

Time frame: Immediately after operation

Success rate of operation

The success of operation refers to the success of instruments and techniques in the operation without serious complications

Time frame: Immediately after operation

Incidence of device defects

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

Time frame: Immediately after operation

Incidence of severe surgical complications

Severe complications included nerve root injury, vascular injury, spinal cord injury, visceral injury and pedicle fracture

Time frame: Discharge or 7 days after surgery, whichever comes first

Incidence of adverse events and serious adverse events

Time frame: Discharge or 7 days after surgery, whichever comes first

Navigation and Positioning System for Orthopedic Surgery

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts