Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2016-01-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Robot
Intervention: Surgery: robot-assisted spine surgery, device: TiRobot surgery system
robot-assisted spine surgery
robot-assisted spine surgery using Tirobot system
TiRobot system
a robot-assisted spine surgery system
Free-hand
Intervention: Surgery: free-hand surgery
free-hand surgery
traditional free-hand surgery
Interventions
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robot-assisted spine surgery
robot-assisted spine surgery using Tirobot system
free-hand surgery
traditional free-hand surgery
TiRobot system
a robot-assisted spine surgery system
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* old thoracolumbar fracture
* deformity of pedicle
* combined with coagulation disorders
* combined with other systematic disease
18 Years
ALL
No
Sponsors
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Beijing Tinavi Medical Technology Co Ltd
UNKNOWN
Chinese PLA General Hospital
OTHER
Tianjin Hospital
OTHER
Beijing Jishuitan Hospital
OTHER
Responsible Party
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Wei Tian
Director
Principal Investigators
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Wei Tian, MD
Role: STUDY_CHAIR
Beijing Jishuitan Hospital
Locations
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Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Countries
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References
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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.
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.
Weinstein JN, Rydevik BL, Rauschning W. Anatomic and technical considerations of pedicle screw fixation. Clin Orthop Relat Res. 1992 Nov;(284):34-46.
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.
Other Identifiers
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JST-Tirobot-2016
Identifier Type: -
Identifier Source: org_study_id
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