Back to resultsEvaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
Primary Purpose
Spine Disease, Spinal Fractures
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
surgical robot
controlled approach
Sponsored by
About this trial
This is an interventional treatment trial for Spine Disease focused on measuring smart orthopedics, minimally invasive surgical systems, spinal surgery
Eligibility Criteria
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 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.
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
Outcomes
Primary Outcome Measures
Incorrect placement of guide pin
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04956588
First Posted
July 2, 2021
Last Updated
July 2, 2021
Sponsor
Peking University Third Hospital
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04956588
Brief Title
Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
Official Title
A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial to Evaluate the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shenzhen Second People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Disease, Spinal Fractures
Keywords
smart orthopedics, minimally invasive surgical systems, spinal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
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).
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
surgical robot
Intervention Description
The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.
Intervention Type
Combination Product
Intervention Name(s)
controlled approach
Intervention Description
The screw placement was performed using a controlled approach according to the surgical plan.
Primary Outcome Measure Information:
Title
Incorrect placement of guide pin
Description
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.
Time Frame
During operation
Title
Number of X-ray exposures
Description
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.
Time Frame
During operation
Title
X-ray exposure time
Description
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.
Time Frame
During operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery
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