Spinal Fractures, Spine Disease
Conditions
Keywords
smart orthopedics, minimally invasive surgical systems, spinal surgery
Brief summary
To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.
Interventions
COMBINATION_PRODUCTsurgical robot
The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.
COMBINATION_PRODUCTcontrolled approach
The screw placement was performed using a controlled approach according to the surgical plan.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Shenzhen Second People's Hospital
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor was blinded when evaluating the subject's imaging data (i.e., when calculating the deviation of the nail placement).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Age 18-65, gender unlimited; In line with the surgical conditions for spinal surgery requiring Kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; Signed the informed consent and agreed to participate in the study; Complete the filter check and meet all the entry criteria in the filter table.
Exclusion criteria
\- Subject meeting the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incorrect placement of guide pin | During operation | After the subject completes the preparation for guide needle placement (e.g. reduction), a C-arm scan is performed. Get the image. Surgical planning is performed on images. Control robot positioning. The doctor completes the insertion of the guide needle. Then the C-arm scan image was obtained again. Fusion of two groups of images on a third-party software. The deviation distance between the entry and exit points of the guide needle and the surgical plan was measured. The accuracy of guide needle placement was evaluated by the deviation of guide needle placement. |
| Number of X-ray exposures | During operation | The number of exposures was defined as the number of times the investigator used the X-ray during the operative period and also included the number of exposures performed to determine the surgical site. |
| X-ray exposure time | During operation | X-ray exposure time refers to the total time of using X-rays from the planning of the operation to the end of the operation. |
Countries
China
Outcome results
None listed