Clinical Trial for the Application of Tirobot System

September 9, 2016 updated by: Wei Tian, Beijing Jishuitan Hospital
The object of this study was to evaluate the accuracy and safety of the Tirobot system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100035
        • Beijing Jishuitan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to postoperative 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: through the operation complete, an average of 2 hours
total operation time of the surgery (time in minutes)
through the operation complete, an average of 2 hours
complications
Time Frame: up to postoperative 3 months
Number of Adverse Events That Are Related to Treatments
up to postoperative 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Jishuitan Hospital

Collaborators

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

Investigators

  • Study Chair: Wei Tian, MD, Beijing Jishuitan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (ESTIMATE)

September 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JST-Tirobot-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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