Screws Implantation Assisted With Mixed Reality Technology

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

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

Study Overview

• Status: Completed
• Conditions: Spine Degeneration
• Intervention / Treatment: Device: Mixed Reality technology

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Mixed Reality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar pedicle screws implantation of traditional procedure; traditional method of lumbar pedicle screws implantation	Device: Mixed Reality technology; combine image with real body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.	6 months
Oswestry Disability Index	Oswestry Disability Index is for movement function, Questionnaire examines	6 months
The Standard Of Gertzbein-Robbins	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.	1 day

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Actual): March 15, 2017
• Study Completion (Actual): October 27, 2018

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KY20170109-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No