Accuracy Study of Robot-assisted Screw Insertion in Spinal Surgery

Beijing Jishuitan Hospital

Status

Unknown

Conditions

the Robot-assisted Technique

Treatments

Device: the TiRobot system

Device: Freehand

Study type

Interventional

Funder types

Other

Identifiers

NCT04040868

JST-201903

Details and patient eligibility

About

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.

Full description

In spinal surgery, the accurate placement of implants is the key to ensure the success of the surgery, to achieve the safety and clinical requirements of internal fixation. Robot-assisted technology has become an effective means to improve the accuracy of implants with higher accuracy, free from fatigue and equivalent repetitive operation. 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.

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 18 or above, gender not limited;
patients eligible for surgery;
the patient signed the informed consent and agreed to participate in this study.

Exclusion criteria

patients with severe osteoporosis;
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.