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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03512379
Other study ID # JST-201508
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2015
Est. completion date December 31, 2021

Study information

Verified date September 2018
Source Beijing Jishuitan Hospital
Contact Mingxing Fan, MD,PHD
Phone +86-13683360600
Email van0208@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
TIANJI Robot
A robotic system for spinal surgery
Fluoroscopy
For fluoroscopy-based free hand surgery
Navigation
For navigation-assisted spinal surgery

Locations

Country Name City State
China Beijing Jishuitan Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Screw guide wire adjustment times The adjustment times of screw guide wire during surgery During surgery
Primary Screw adjustment times The adjustment times of screw during surgery During surgery
Primary Deviation of screw The deviation between the actual position of screw and the preoperative designed position Up to 12 weeks
Primary Perforation rate of screw Rate of screws breaching out pedicles on postoperative CT image Up to 12 weeks
Secondary Operation time Operation time During surgery
Secondary Blood loss Blood loss during surgery During surgery
Secondary Complications Complications after surgery Up to 4 weeks
Secondary Hospital stay after surgery Hospital stay after surgery Up to 4 weeks
Secondary Hospitalization costs Hospitalization costs Up to 4 weeks
Secondary Visual Analogue Scale Visual Analogue Scale 3 days before surgery
Secondary Visual Analogue Scale Visual Analogue Scale 3 days after surgery
Secondary Neck Disability Index Neck Disability Index 3 days before surgery
Secondary Neck Disability Index Neck Disability Index 3 days after surgery
Secondary Oswestry Disability Index Oswestry Disability Index 3 days before surgery
Secondary Oswestry Disability Index Oswestry Disability Index 3 days after surgery
Secondary modified Japanese orthopaedic association score modified Japanese orthopaedic association score 3 days before surgery
Secondary modified Japanese orthopaedic association score modified Japanese orthopaedic association score 3 days after surgery
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