NCT02890043

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

August 21, 2016

Last Update Submit

September 9, 2016

Conditions

Fusion of Spine (Disease)Robotic Surgical Procedures

Keywords

spinerobot-assisted surgerypedicle screw

Outcome Measures

Primary Outcomes (1)

  • perforation rate of pedicle screws

    number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number

    up to postoperative 3 days

Secondary Outcomes (2)

  • operation time

    through the operation complete, an average of 2 hours

  • complications

    up to postoperative 3 months

Study Arms (2)

Robot

EXPERIMENTAL

Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system

Procedure: robot-assisted spine surgeryDevice: TiRobot system

Free-hand

ACTIVE COMPARATOR

Intervention: Surgery: free-hand surgery

Procedure: free-hand surgery

Interventions

robot-assisted spine surgeryPROCEDURE

robot-assisted spine surgery using Tirobot system

Robot
free-hand surgeryPROCEDURE

traditional free-hand surgery

Free-hand
TiRobot systemDEVICE

a robot-assisted spine surgery system

Robot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery

You may not qualify if:

  • severe osteoporosis
  • old thoracolumbar fracture
  • deformity of pedicle
  • combined with coagulation disorders
  • combined with other systematic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Related Publications (4)

  • Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab.

    PMID: 21079498RESULT

  • Karapinar L, Erel N, Ozturk H, Altay T, Kaya A. Pedicle screw placement with a free hand technique in thoracolumbar spine: is it safe? J Spinal Disord Tech. 2008 Feb;21(1):63-7. doi: 10.1097/BSD.0b013e3181453dc6.

    PMID: 18418139RESULT

  • Weinstein JN, Rydevik BL, Rauschning W. Anatomic and technical considerations of pedicle screw fixation. Clin Orthop Relat Res. 1992 Nov;(284):34-46.

    PMID: 1395312RESULT

  • Han X, Tian W, Liu Y, Liu B, He D, Sun Y, Han X, Fan M, Zhao J, Xu Y, Zhang Q. Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery: a prospective randomized controlled trial. J Neurosurg Spine. 2019 Feb 8;30(5):615-622. doi: 10.3171/2018.10.SPINE18487. Print 2019 May 1.

    PMID: 30738398DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Tian, MD

    Beijing Jishuitan Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 21, 2016

First Posted

September 7, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

CN(1)