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OpenTrials
Completed

NCT Number: NCT05545709

5G-based Telerobot-assisted Spine Surgery

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Jishuitan hospital

Beijing, Beijing Municipality, 100000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

remote robot-assisted spine surgery

Procedure

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 outcomes

  1. The accuracy of guide-wire placement or positioning

    Time frame: 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 outcomes

  1. operation time

    Time frame: 1 day

    Time from start to finish of surgery

  2. complication

    Time frame: 1 month

    Nerve injury, epidural hematoma, and infection

  3. network interruptions

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 19, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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