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CompletedNCT04062487Updated Aug 20, 2019

Screws Implantation Assisted With Mixed Reality Technology

An interventional study of Mixed Reality technology in Spine Degeneration, sponsored by Nanjing First Hospital, Nanjing Medical University. Completed at 1 site in China. Open to participants aged 38 Years to 53 Years. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jan 2017, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
38 Years to 53 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Spine Degeneration
03

In context

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
38 Years to 53 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Lumbar pedicle screws implantation of traditional procedure

    traditional method of lumbar pedicle screws implantation

    Device: Mixed Reality technology

Interventions

  • DeviceMixed Reality technology

    combine image with real body

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

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

    Time frame: 6 months

  2. Oswestry Disability Index

    Oswestry Disability Index is for movement function, Questionnaire examines

    Time frame: 6 months

  3. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Mixed Reality
    Nanjing, Jiangsu 210029, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04062487
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
Aug 20, 2019
Start date
Jan 9, 2017
Primary completion
Mar 15, 2017
Completion
Oct 27, 2018
Last update
Aug 20, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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