Screws Implantation Assisted With Mixed Reality Technology

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

Detailed Description
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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.

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

Conditions
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Spine Degeneration

Intervention / Treatment
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* Device: Mixed Reality technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar pedicle screws implantation of traditional procedure<br>traditional method of lumbar pedicle screws implantation | Device: Mixed Reality technology<br>* combine image with real body<br>|

What is the study measuring?
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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 |