Accuracy Study of Robot-assisted Screw Insertion in Spinal Surgery
NCT ID: NCT04040868
Last Updated: 2019-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2019-03-01
2020-06-30
Brief Summary
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Detailed Description
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500 participants per group (1000 participants in total) are being recruited after diagnosis and before treatment through multi-hospital system and randomised to 1) robot-assisted technique or 2) conventional fluoroscopy-assisted technique in spine surgery. Outcomes are being measured pre-operatively, during- surgery and at 3, 6, 12 months post-surgery. 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.
The study is addressing key questions of importance by evaluating the TiRobot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter. Outputs include evidence to facilitate more effective and safe decision making about surgical treatment for spine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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robot-assisted technique
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
conventional fluoroscopy-assisted technique
Freehand
conventional fluoroscopy-assisted
Interventions
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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
Freehand
conventional fluoroscopy-assisted
Eligibility Criteria
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Inclusion Criteria
* patients eligible for surgery;
* the patient signed the informed consent and agreed to participate in this study.
Exclusion Criteria
* patients with old fractures;
* patients with developmental deformity of the vertebral body with screw placement;
* patients complicated with severe systemic diseases;
* patients with coagulation dysfunction;
* patients deemed unsuitable for the test by the clinical institution.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Jishuitan Hospital
OTHER
Responsible Party
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Wei Tian
President of Beijing Jishuitan Hospital
Locations
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Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Fan M, Fang Y, Zhang Q, Zhao J, Liu B, Tian W. A prospective cohort study of the accuracy and safety of robot-assisted minimally invasive spinal surgery. BMC Surg. 2022 Feb 11;22(1):47. doi: 10.1186/s12893-022-01503-4.
Other Identifiers
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JST-201903
Identifier Type: -
Identifier Source: org_study_id
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