Clinical Trial for the Application of Robotic System in Spinal Surgery

Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study

This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.

Study Overview

• Status: Unknown
• Conditions: Robotic Surgical Procedures; Spinal Surgery; Safety
• Intervention / Treatment: Device: TIANJI Robot; Device: Fluoroscopy; Device: Navigation

Detailed Description

Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mingxing fan, MD,PHD; Phone Number: +86-13683360600; Email: van0208@163.com
• Study Contact Backup: Name: Yajun Liu, MD,PHD; Phone Number: +86-13911878647; Email: drliuyajun@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100035
      • Recruiting
      • Beijing Jishuitan Hospital
      • Contact: Weijun Zhang, MD; Phone Number: 010-82156660; Email: zhangweijun@tinavi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Spinal disease required for screw fixation；signed the inform consent

Exclusion Criteria:

• Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot assisted surgery group; Spinal surgery using TIANJI Robot system.	Device: TIANJI Robot; A robotic system for spinal surgery
Active Comparator: Free hand surgery group; Spinal surgery using fluoroscopy-based free hand technique	Device: Fluoroscopy; For fluoroscopy-based free hand surgery
Active Comparator: Navigation-assisted surgery group; Spinal surgery using Navigation-assisted technique	Device: Navigation; For navigation-assisted spinal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screw guide wire adjustment times	The adjustment times of screw guide wire during surgery	During surgery
Screw adjustment times	The adjustment times of screw during surgery	During surgery
Deviation of screw	The deviation between the actual position of screw and the preoperative designed position	Up to 12 weeks
Perforation rate of screw	Rate of screws breaching out pedicles on postoperative CT image	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	Operation time	During surgery
Blood loss	Blood loss during surgery	During surgery
Complications	Complications after surgery	Up to 4 weeks
Hospital stay after surgery	Hospital stay after surgery	Up to 4 weeks
Hospitalization costs	Hospitalization costs	Up to 4 weeks
Visual Analogue Scale	Visual Analogue Scale	3 days before surgery
Visual Analogue Scale	Visual Analogue Scale	3 days after surgery
Neck Disability Index	Neck Disability Index	3 days before surgery
Neck Disability Index	Neck Disability Index	3 days after surgery
Oswestry Disability Index	Oswestry Disability Index	3 days before surgery
Oswestry Disability Index	Oswestry Disability Index	3 days after surgery
modified Japanese orthopaedic association score	modified Japanese orthopaedic association score	3 days before surgery
modified Japanese orthopaedic association score	modified Japanese orthopaedic association score	3 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Investigators: Study Chair: Wei Tian, MD,PHD, Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: spine; pedicle screw; robot-assisted surgery
• Other Study ID Numbers: JST-201508

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No