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Completed

NCT Number: NCT04956588

Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.

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Key information

Conditions

Spine Disease Back Injuries Bone Diseases Fractures, Bone Musculoskeletal Diseases Spinal Diseases Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Third Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-65, gender unlimited; In line with the surgical conditions for spinal surgery requiring Kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; Signed the informed consent and agreed to participate in the study; Complete the filter check and meet all the entry criteria in the filter table.

Exclusion criteria

  • Subject meeting the exclusion criteria; People with metal allergy; Women who are lactating or pregnant, and the possibility of pregnancy cannot be ruled out; Subjects with coagulation dysfunction; Subjects who have failed spinal surgery and need a second operation; Subjects with spinal tumors, deformities and slippery vertebrae; Candidates who have participated in clinical trials related to other drugs and medical devices within the past 3 months; Any other circumstances in which the Investigator deems it inappropriate to participate in this study.

Treatment and study plan

surgical robot

Combination Product

The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.

controlled approach

Combination Product

The screw placement was performed using a controlled approach according to the surgical plan.

Primary outcomes

  1. Incorrect placement of guide pin

    Time frame: During operation

    After the subject completes the preparation for guide needle placement (e.g. reduction), a C-arm scan is performed. Get the image. Surgical planning is performed on images. Control robot positioning. The doctor completes the insertion of the guide needle. Then the C-arm scan image was obtained again. Fusion of two groups of images on a third-party software. The deviation distance between the entry and exit points of the guide needle and the surgical plan was measured. The accuracy of guide needle placement was evaluated by the deviation of guide needle placement.

  2. Number of X-ray exposures

    Time frame: During operation

    The number of exposures was defined as the number of times the investigator used the X-ray during the operative period and also included the number of exposures performed to determine the surgical site.

  3. X-ray exposure time

    Time frame: During operation

    X-ray exposure time refers to the total time of using X-rays from the planning of the operation to the end of the operation.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Shenzhen Second People's Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Registry information

Official study title

A Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial to Evaluate the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2021
Registry last updated
Jul 9, 2021

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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