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Accuracy Study of Robot-assisted Screw Insertion in Spinal Surgery

NCT04040868 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2019-08-01

No results posted yet for this study

Summary

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.

Conditions

  • the Robot-assisted Technique

Interventions

DEVICE

the TiRobot system

The TiRobot system (TINAVI Medical Technologies Co. Ltd.) is a multi-indication orthopedic surgical robot that can be used in spinal, pelvic, and limb surgeries performed via an open or a minimally invasive approach

DEVICE

Freehand

conventional fluoroscopy-assisted

Sponsors & Collaborators

  • Beijing Jishuitan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-03-31
Completion
2020-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04040868 on ClinicalTrials.gov