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Completed

NCT Number: NCT02890043

Clinical Trial for the Application of Tirobot System

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

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Key information

Conditions

Fusion of Spine (Disease) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Robotic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

robot-assisted spine surgery

Procedure

robot-assisted spine surgery using Tirobot system

Free-Hand Surgery

Procedure

traditional free-hand surgery

TiRobot system

Device

a robot-assisted spine surgery system

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Collaborators

  • Beijing Tinavi Medical Technology Co Ltd
  • Chinese PLA General Hospital
  • Tianjin Hospital

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2016
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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