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Clinical Trial for the Application of Tirobot System

B

Beijing Jishuitan Hospital

Status and phase

Completed
Phase 3

Conditions

Fusion of Spine (Disease)
Robotic Surgical Procedures

Treatments

Device: TiRobot system
Procedure: robot-assisted spine surgery
Procedure: free-hand surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02890043
JST-Tirobot-2016

Details and patient eligibility

About

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

Full 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.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

88 participants in 2 patient groups

Robot
Experimental group
Description:
Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system
Treatment:
Procedure: robot-assisted spine surgery
Device: TiRobot system
Free-hand
Active Comparator group
Description:
Intervention: Surgery: free-hand surgery
Treatment:
Procedure: free-hand surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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