Skip to main content
OpenTrials
Completed

NCT Number: NCT04062487

Screws Implantation Assisted With Mixed Reality Technology

Prospective comparative study of Mixed Reality Technology(MR)assisted lumbar pedicle screws placement and traditional lumbar pedicle screws placement.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

38 year–53 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mixed Reality

Nanjing, Jiangsu, 210029, China

About this study

In this study, the randomized controlled method was adopted to prospectively include the samples, and the differences in surgical procedures and efficacy were compared between the thoracolumbar pedicle screw implantation assisted by MR and the traditional thoracolumbar pedicle screw implantation, so as to provide a plan for clinicians to choose the surgical method.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Course of disease≥6 months, all patients with lumbago back pain, radiation pain of lower limbs, lumbar disc herniation diagnosed with or without spinal stenosis.
  • The course of disease≥6 months, all patients had lumbar back pain, accompanied by or without intermittent claudication, and the diagnosis of lumbar spondylolisthesis was clear, but the vertebral isthmus was not broken.
  • The patient's symptoms were consistent with the imaging examination results, failed to respond to conservative treatment, and met the surgical indications.
  • The lesion segment is no more than 3 vertebral bodies.
  • Preoperative improvement of X-ray, CT, MRI examination.
  • Patients without active bleeding and female patients is not in menstrual period.

Exclusion criteria

  • Lumbar acute infection, lumbar tuberculosis, tumor and other diseases.
  • Patients with severe cardiopulmonary insufficiency, intolerance to surgery, diabetes and poor blood glucose control, combined with coagulation dysfunction and other contraindications.
  • Vertebral fracture patients.
  • Bone Mineral Density (BMD) examination: BMD was measured by dual-energy X- ray absorptiometry at the lumbar spine (L2 ~ L4) and femoral head, and BMD and T values were observed. Abnormal bone mass were excluded according T >- 1 SD

Treatment and study plan

Mixed Reality technology

Device

combine image with real body

Primary outcomes

  1. Visual Analog Scale

    Time frame: 6 months

    visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.

  2. Oswestry Disability Index

    Time frame: 6 months

    Oswestry Disability Index is for movement function, Questionnaire examines

  3. The Standard Of Gertzbein-Robbins

    Time frame: 1 day

    the standard of Gertzbein-Robbins :Ⅰ, self-contained complete within the pedicle nail; Ⅱ, self-contained nail through 2 mm below the cortex; Ⅲ, self-contained nail through 2 mm or greater, cortex < 4 mm; Nail through 4 mm or higher cortex; Ⅳ, self-contained, < 6 mm; Ⅴ, self-contained nail through 6 mm or higher cortex.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

A Clinical Application Study of Mixed Reality Technology Assisted Lumbar Pedicle Screws Implantation

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 20, 2019
Registry last updated
Aug 20, 2019

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.

Published trials that share one or more normalized conditions with this study.