5G-based Telerobot-assisted Spine Surgery

Sponsor
Beijing Jishuitan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05545709
Collaborator
(none)
192
1
15
12.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: remote robot-assisted spine surgery

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 Design

Study Type:
Observational
Actual Enrollment :
192 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical Application of 5G-based Telerobot-assisted Spine Surgery
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
remote group

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.

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.

local group

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. operation time [1 day]

    Time from start to finish of surgery

  2. complication [1 month]

    Nerve injury, epidural hematoma, and infection

  3. network interruptions [1 day]

    failure to establish connection, the interruption of connection and severe delays in connection, and remote surgery abandonment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Jishuitan hospital Beijing Beijing China 100000

Sponsors and Collaborators

  • Beijing Jishuitan Hospital

Investigators

  • Principal Investigator: Wei Tian, Beijing Jishuitan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wei Tian, Clinical Professor, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier:
NCT05545709
Other Study ID Numbers:
  • JST 202005-08
First Posted:
Sep 19, 2022
Last Update Posted:
Sep 19, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 19, 2022