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Accuracy Study of Robot-assisted Screw Insertion in Spinal Surgery

NCT04040868 · Beijing Jishuitan Hospital · Updated 1 Aug 2019

What is being tested
the TiRobot system; Freehand
For
the Robot-assisted Technique
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 1,000 people. The full rules are on the registry page.
Where
China
When
Starts or started 1 March 2019, ends June 2020. Registered 1 Aug 2019.
Results
None posted yet.

In the researchers' words

The investigators present the design of a randomized trial to compare the accuracy and safety of screw insertion using the robot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter. The accuracy and safety of screw insertion are measured by deviation of guide pin placement position, deviation of screw placement position, and intraoperative or postoperative complications. Secondary outcome parameters such as radiation exposure, postoperative recovery, duration of surgery, length of hospital stay and economic appraisal were also evaluated and compared between treatment groups.
ClinicalTrials.gov, NCT04040868

Sites

  • Beijing Jishuitan HospitalBeijing, Beijing Municipality, China