Screws Implantation Assisted With Mixed Reality Technology

Spine Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062487
• Other study ID #: KY20170109-04
• Status: Completed
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: October 27, 2018

Study information

• Verified date: August 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 27, 2018
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Years to 53 Years

Eligibility

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

Related Conditions & MeSH terms

• Spine Degeneration

Intervention

Device:
• Mixed Reality technology
combine image with real body

Locations

Country	Name	City	State
China	Mixed Reality	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.	6 months
Primary	Oswestry Disability Index	Oswestry Disability Index is for movement function, Questionnaire examines	6 months
Primary	The Standard Of Gertzbein-Robbins	the standard of Gertzbein-Robbins :?, self-contained complete within the pedicle nail; ?, self-contained nail through 2 mm below the cortex; ?, self-contained nail through 2 mm or greater, cortex < 4 mm; Nail through 4 mm or higher cortex; ?, self-contained, < 6 mm; ?, self-contained nail through 6 mm or higher cortex.	1 day