Clinical Trial for the Application of Tirobot System

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

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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