Clinical trial NCT04040868: Accuracy Study of Robot-assisted Screw Insertion in Spinal Surgery
Official title: Safety and Accuracy of Robot-assisted Versus Fluoroscopy-assisted Screw Insertion in Spinal Surgery: a Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: the Robot-assisted Technique
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Deviation of guide pin placement position
timeFrame: during operation
measure: Time of guide pin adjustion
timeFrame: during operation
measure: Deviation of screw placement position
timeFrame: during operation
measure: Time of screw adjustion
timeFrame: during operation
measure: Intraoperative Complications
timeFrame: After operation up to 4 weeks
measure: Postoperative Complications
timeFrame: The time was within 1 year after the operation.
Secondary outcomes:
measure: Duration of surgery
timeFrame: during operation
measure: Radiation exposure
timeFrame: during operation
measure: Visual analogue scale (VAS) score 24 hours before surgery
timeFrame: 24 hours before surgery
measure: Visual analogue scale (VAS) score 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Visual analogue scale (VAS) score 3 months after surgery
timeFrame: 3 months after surgery
measure: Visual analogue scale (VAS) score 6 months after surgery
timeFrame: 6 months after surgery
measure: Visual analogue scale (VAS) score 1 year after surgery
timeFrame: 1 year after surgery
measure: JOA score 24 hours before surgery
timeFrame: 24 hours before surgery
measure: JOA score 24 hours after surgery
timeFrame: 24 hours after surgery
measure: JOA score 3 months after surgery
timeFrame: 3 months after surgery
measure: JOA score 6 months after surgery
timeFrame: 6 months after surgery
measure: JOA score 1 year after surgery
timeFrame: 1 year after surgery
measure: NDI score 24 hours before surgery
timeFrame: 24 hours before surgery
measure: NDI score 24 hours after surgery
timeFrame: 24 hours after surgery
measure: NDI score 3 months after surgery
timeFrame: 3 months after surgery
measure: NDI score 6 months after surgery
timeFrame: 6 months after surgery
measure: NDI score 1 year after surgery
timeFrame: 1 year after surgery
measure: ODI score 24 hours before surgery
timeFrame: 24 hours before surgery
measure: ODI score 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Health related quality of life 3 months after surgery
timeFrame: 3 months after surgery
measure: Health related quality of life 6 months after surgery
timeFrame: 6 months after surgery
measure: Health related quality of life 1 year after surgery
timeFrame: 1 year after surgery
measure: Economic appraisal
timeFrame: The time was within 1 year after the operation.
measure: length of hospital stay
timeFrame: Up to the 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
Study officials:
References:
citation: 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.