Screws Implantation Assisted With Mixed Reality Technology

Not Applicable

Completed

• Conditions: Spine Degeneration
• Interventions: Device: Mixed Reality technology

• Registration Number: NCT04062487
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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

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 Timeline

• Study Start: 2017-01-09
• Primary Completion: 2017-03-15
• Study Completion: 2018-10-27
• Status Verified: 2019-08
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Last Update Submitted: 2019-08-19
• Study First Posted: 2019-08-20
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lumbar pedicle screws implantation of traditional procedure	Mixed Reality technology	traditional method of lumbar pedicle screws implantation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mixed Reality; 🇨🇳 Nanjing, Jiangsu, China