Screws Implantation Assisted With Mixed Reality Technology

Nanjing Medical University

Status

Completed

Conditions

Spine Degeneration

Treatments

Device: Mixed Reality technology

Study type

Interventional

Funder types

Other

Identifiers

NCT04062487

KY20170109-04

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

38 to 53 years old

Volunteers

No Healthy Volunteers

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