5G-based Telerobot-assisted Spine Surgery

Surgery Clinical Trial

Official title:

Clinical Application of 5G-based Telerobot-assisted Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05545709
• Other study ID #: JST 202005-08
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of guide-wire placement or positioning	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).	1 month
Secondary	operation time	Time from start to finish of surgery	1 day
Secondary	complication	Nerve injury, epidural hematoma, and infection	1 month
Secondary	network interruptions	failure to establish connection, the interruption of connection and severe delays in connection, and remote surgery abandonment.	1 day