Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02890043
NCT02890043
Completed
Phase 3

Clinical Trial for the Application of Tirobot System

Beijing Jishuitan Hospital1 site in 1 country88 target enrollmentJanuary 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsFusion of Spine (Disease)Robotic Surgical Procedures

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Fusion of Spine (Disease)
Sponsor
Beijing Jishuitan Hospital
Enrollment
88
Locations
1
Primary Endpoint
perforation rate of pedicle screws
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Tian

Director

Beijing Jishuitan Hospital

Eligibility 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

Outcomes

Primary Outcomes

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

  • operation time(through the operation complete, an average of 2 hours)
  • complications(up to postoperative 3 months)

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
Clinical Trial for the Application of Robotic System in Spinal SurgeryRobotic Surgical ProceduresSpinal SurgerySafety
NCT03512379Beijing Jishuitan Hospital1,000
Unknown
Not Applicable
Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract SurgeryIolAstigmatism
NCT02618018Seoul National University Hospital20
Completed
Not Applicable
Safety and Performance Study of the Moderato SystemHypertension Resistant to Conventional TherapyBradycardiaAtrioventricular Block
NCT02282033BackBeat Medical Inc57
Completed
Not Applicable
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery LesionsCoronary Artery Disease
NCT01426139Biotronik AG120
Completed
Not Applicable
Safety and Effectiveness of an Auricular SprayExcessive Ear Wax
NCT06085443YSLab99