MedTrace Logo

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

NCT04956588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-07-09

No results posted yet for this study

Summary

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.

Conditions

  • Spine Disease
  • Spinal Fractures

Interventions

COMBINATION_PRODUCT

surgical robot

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

COMBINATION_PRODUCT

controlled approach

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

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956588 on ClinicalTrials.gov