Status:
COMPLETED
Screws Implantation Assisted With Mixed Reality Technology
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Spine Degeneration
Eligibility:
All Genders
38-53 years
Phase:
NA
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 pedicl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04062487
Start Date
January 9 2017
End Date
October 27 2018
Last Update
August 20 2019
Active Locations (1)
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1
Mixed Reality
Nanjing, Jiangsu, China, 210029