5G-based Telerobot-assisted Spine Surgery

Completed

• Conditions: Surgery
• Interventions: Procedure: remote robot-assisted spine surgery

• Registration Number: NCT05545709
• Lead Sponsor: Beijing Jishuitan Hospital

Brief Summary

This study retrospectively analyzed cases of remote robot-assisted spine surgery performed jointly by the Beijing Jishuitan Hospital Spinal Surgery and partner hospitals, with cases of local orthopedic robot-assisted spine surgeries performed by Beijing Jishuitan Hospital between April 2021 and December 2021.

Detailed Description

Local orthopedic robot-assisted spine surgeries were performed according to the guidelines for thoracolumbar pedicle screw placement assisted by orthopedic surgical robots.

Based on the 5G network, the orthopedic robotic remote surgery platform is built at Beijing Jishuitan Hospital, providing primary hospitals with a platform for preoperative consultation, intraoperative communication and surgical robot teleoperation, and postoperative follow-up. With the support of the 5G network, equipment and surgical robots are integrated into the remote surgery service platform, building a high-speed transmission channel between Beijing Jishuitan Hospital and other hospitals.

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-19
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• patients received remote robot-assisted spinal surgery or local orthopedic robot-assisted spinal surgery;
• patients had complete medical records and imaging data;
• patients provided informed consent.

Exclusion Criteria

• revision surgery;
• more than four surgical segments;
• patients with severe comorbidities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
remote group	remote robot-assisted spine surgery	Based on the 5G network, the orthopedic robotic remote surgery platform is built at Beijing Jishuitan Hospital, providing primary hospitals with a platform for preoperative consultation, intraoperative communication and surgical robot teleoperation, and postoperative follow-up. With the support of the 5G network, equipment and surgical robots are integrated into the remote surgery service platform, building a high-speed transmission channel between Beijing Jishuitan Hospital and other hospitals.

Primary Outcome Measures

Name	Time	Method
The accuracy of guide-wire placement or positioning	1 month	according to the Gertzbein and Robbins scale, including grade A (screw was completely within the pedicle), grade B (pedicle cortical breach \<2 mm), grade C (pedicle cortical breach \<4 mm), grade D (pedicle cortical breach \<6 mm), and grade E (pedicle cortical breach \>6 mm).

Secondary Outcome Measures

Name	Time	Method
operation time	1 day	Time from start to finish of surgery
complication	1 month	Nerve injury, epidural hematoma, and infection
network interruptions	1 day	failure to establish connection, the interruption of connection and severe delays in connection, and remote surgery abandonment.

Trial Locations

Locations (1)

Beijing Jishuitan hospital; 🇨🇳 Beijing, Beijing, China