Clinical Trial for the Application of Tirobot System

Robotic Surgical Procedures Clinical Trial

Official title:

Clinical Trial for the Application of Tirobot System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890043
• Other study ID #: JST-Tirobot-2016
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2016
• Last updated: September 9, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fusion of Spine (Disease)
• Robotic Surgical Procedures

Intervention

Procedure:
• robot-assisted spine surgery
robot-assisted spine surgery using Tirobot system
• free-hand surgery
traditional free-hand surgery

Device:
• TiRobot system
a robot-assisted spine surgery system

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital	Beijing Tinavi Medical Technology Co Ltd, Chinese PLA General Hospital, Tianjin Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stüer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perforation rate of pedicle screws	number of pedicle screws breaching out pedicles on postoperative CT image/ total screw number	up to postoperative 3 days	No
Secondary	operation time	total operation time of the surgery (time in minutes)	through the operation complete, an average of 2 hours	No
Secondary	complications	Number of Adverse Events That Are Related to Treatments	up to postoperative 3 months	Yes