Screws Implantation Assisted With Mixed Reality Technology

NCT04062487 | Completed

• 1 other identifier: KY20170109-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spine Degeneration

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale

  visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.

  6 months

• Oswestry Disability Index

  Oswestry Disability Index is for movement function, Questionnaire examines

  6 months

• The Standard Of Gertzbein-Robbins

  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.

  1 day

Study Arms (1)

Lumbar pedicle screws implantation of traditional procedure

EXPERIMENTAL

traditional method of lumbar pedicle screws implantation

Device: Mixed Reality technology

Interventions

Mixed Reality technology DEVICE

combine image with real body

Lumbar pedicle screws implantation of traditional procedure

Eligibility Criteria

• Age: 38 Years - 53 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Mixed Reality

Nanjing, Jiangsu, 210029, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 20, 2019
• Study Start: January 9, 2017
• Primary Completion: March 15, 2017
• Study Completion: October 27, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

CN (1)