Clinical Trial for the Application of Robotic System in Spinal Surgery
1 other identifier
interventional
1,000
1 country
1
Brief Summary
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 24, 2018
September 1, 2018
5.4 years
April 3, 2018
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (13)
Operation time
During surgery
Blood loss
During surgery
Complications
Up to 4 weeks
Hospital stay after surgery
Up to 4 weeks
Hospitalization costs
Up to 4 weeks
- +8 more secondary outcomes
Study Arms (3)
Robot assisted surgery group
EXPERIMENTALSpinal surgery using TIANJI Robot system.
Free hand surgery group
ACTIVE COMPARATORSpinal surgery using fluoroscopy-based free hand technique
Navigation-assisted surgery group
ACTIVE COMPARATORSpinal surgery using Navigation-assisted technique
Interventions
Eligibility Criteria
You may qualify if:
- Spinal disease required for screw fixationï¼›signed the inform consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wei Tian, MD,PHD
Beijing Jishuitan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 30, 2018
Study Start
August 1, 2015
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
September 24, 2018
Record last verified: 2018-09