Navigation and Positioning System for Orthopedic Surgery

Nanjing Tuodao Medical Technology

Status: Unknown

Conditions: Pedicle Screw Fixation of Spine

Treatments: Device: Navigation and Positioning System for Orthopedic Surgeries

Study type: Interventional

Funder types: Other

Identifiers

NCT04883580

2021-MD-100

Details and patient eligibility

About

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

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

experimental group

Experimental group

Treatment:

Device: Navigation and Positioning System for Orthopedic Surgeries

control group

Active Comparator group

Treatment:

Device: Navigation and Positioning System for Orthopedic Surgeries