Screws Implantation Assisted With Mixed Reality Technology

NCT ID: NCT04062487

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2018-10-27

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.

Conditions

Spine Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lumbar pedicle screws implantation of traditional procedure

traditional method of lumbar pedicle screws implantation

Group Type: EXPERIMENTAL

Mixed Reality technology

Intervention Type: DEVICE

combine image with real body

Interventions

Mixed Reality technology

combine image with real body

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mixed Reality

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

KY20170109-04

Identifier Type: -

Identifier Source: org_study_id