Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

Phase 3

Completed

• Conditions: Spine Disease; Spinal Fractures
• Interventions: Combination Product: surgical robot; Combination Product: controlled approach

• Registration Number: NCT04956588
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-09
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

• Subject meeting the exclusion criteria; People with metal allergy; Women who are lactating or pregnant, and the possibility of pregnancy cannot be ruled out; Subjects with coagulation dysfunction; Subjects who have failed spinal surgery and need a second operation; Subjects with spinal tumors, deformities and slippery vertebrae; Candidates who have participated in clinical trials related to other drugs and medical devices within the past 3 months; Any other circumstances in which the Investigator deems it inappropriate to participate in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	surgical robot	-
control group	controlled approach	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China