Spine DegenerationNCT04062487
Screws Implantation Assisted With Mixed Reality Technology
A study testing Mixed Reality technology in people with Spine Degeneration, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Prospective comparative study of Mixed Reality Technology（MR）assisted lumbar pedicle screws placement and traditional lumbar pedicle screws placement. Read more about this study
- Who is it for?
- Ages 38 to 53 years
- Conditions the study is for
- Spine Degeneration
- What is being tested?
- Mixed Reality technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2017to 27 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 53 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Application Study of Mixed Reality Technology Assisted Lumbar Pedicle Screws Implantation
Prospective comparative study of Mixed Reality Technology（MR）assisted lumbar pedicle screws placement and traditional lumbar pedicle screws placement.
Read the 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
- Being tested
- Mixed Reality technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Reality technologyDevice
combine image with real body
| Study group | Role | What they receive |
|---|---|---|
| Lumbar pedicle screws implantation of traditional procedure | Experimental | traditional method of lumbar pedicle screws implantation Receives: Device: Mixed Reality technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Measured: 6 months
Oswestry Disability Index
Oswestry Disability Index is for movement function, Questionnaire examines
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start9 Jan 2017
- Primary completion15 Mar 2017
- Study completion27 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DegenerationStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062487
- Sponsor's protocol ID
- KY20170109-04
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Application Study of Mixed Reality Technology Assisted Lumbar Pedicle Screws Implantation
- ClinicalTrials.gov ID
- NCT04062487
- Acronym / sponsor ID
- KY20170109-04
- Conditions
- Spine Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 27 Oct 2018 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar pedicle screws implantation of traditional procedure | Experimental | Device: Mixed Reality technologytraditional method of lumbar pedicle screws implantation |
Who may qualify
- Ages
- 38 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Reality technologycombine image with real body | Device | Lumbar pedicle screws implantation of traditional procedure |
Primary outcome
Visual Analog Scale
Time frame: 6 months
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Oswestry Disability Index
Time frame: 6 months
Oswestry Disability Index is for movement function, Questionnaire examines
The Standard Of Gertzbein-Robbins
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Reality technology in people with Spine Degeneration, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.