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Clinical Trial for the Application of Tirobot System

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ClinicalTrials.gov Identifier: NCT02890043
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 12, 2016
Sponsor:
Collaborators:
Beijing Tinavi Medical Technology Co Ltd
Chinese PLA General Hospital
Tianjin Hospital
Information provided by (Responsible Party):
Wei Tian, Beijing Jishuitan Hospital

Brief Summary:
The object of this study was to evaluate the accuracy and safety of the Tirobot system.

Condition or disease Intervention/treatment Phase
Fusion of Spine (Disease) Robotic Surgical Procedures Procedure: robot-assisted spine surgery Procedure: free-hand surgery Device: TiRobot system Phase 3

Detailed Description:
Tirobot system is a new-type medical robot-assisted surgery system that designed for spine and traumatic orthopaedic surgeries. This system has been certified by CE. The accuracy and safety of pedicle screw placement using this system will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial for the Application of Tirobot System
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Robot
Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system
Procedure: robot-assisted spine surgery
robot-assisted spine surgery using Tirobot system

Device: TiRobot system
a robot-assisted spine surgery system

Active Comparator: Free-hand
Intervention: Surgery: free-hand surgery
Procedure: free-hand surgery
traditional free-hand surgery




Primary Outcome Measures :
  1. perforation rate of pedicle screws [ Time Frame: up to postoperative 3 days ]
    number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number


Secondary Outcome Measures :
  1. operation time [ Time Frame: through the operation complete, an average of 2 hours ]
    total operation time of the surgery (time in minutes)

  2. complications [ Time Frame: up to postoperative 3 months ]
    Number of Adverse Events That Are Related to Treatments



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery

Exclusion Criteria:

  • severe osteoporosis
  • old thoracolumbar fracture
  • deformity of pedicle
  • combined with coagulation disorders
  • combined with other systematic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890043


Locations
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China, Beijing
Beijing Jishuitan Hospital
Beijing, Beijing, China, 100035
Sponsors and Collaborators
Beijing Jishuitan Hospital
Beijing Tinavi Medical Technology Co Ltd
Chinese PLA General Hospital
Tianjin Hospital
Investigators
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Study Chair: Wei Tian, MD Beijing Jishuitan Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wei Tian, Director, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT02890043    
Other Study ID Numbers: JST-Tirobot-2016
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Wei Tian, Beijing Jishuitan Hospital:
spine
robot-assisted surgery
pedicle screw