Orthopedic Disorder of SpineNCT03959059
PKP Assisted With MR Technology in OVCF With IVC
A study testing Mixed Reality technology in people with Orthopedic Disorder of Spine, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Orthopedic Disorder of Spine
- 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 20 Mar 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single level OVCF in the thoracic and lumbar levels (T10-L4), suffering with severe back pain.;
- OVCF without damaged vertebral posterior wall and nerve lesion;
- The patient was over 50 years old and , the diagnosis of osteopenia or osteoporosis was confirmed by bone densitometry ;
- All patients underwent（received） plain radiography, computed tomography (CT) and MRI before surgery, and with IVC presented in MRI.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.
Read the detailed description
The study is to prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and post-operation. The volume of injected cement and Operation time was recorded. And whether cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological evidence were also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12 months.
- Conditions
- Orthopedic Disorder of Spine
- 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 |
|---|---|---|
| PKP of traditional procedure | Experimental | traditional method of PKP 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: 1 year
Oswestry Disability Index
Oswestry Disability Index is for movement function, Questionnaire examines perceived level of disability in everyday activities of daily living. The ODI score (index) is calculated as: For example: If all 10 sections are completed, the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%; If one section is missed (or not applicable), the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%.
Measured: 1 year
Vertebral height
Vertebral height in X-ray is for recontruction of the vertebra.
Measured: 1 year
Kyphotic angle
kyphotic angle in X-ray is also for recontruction of the vertebra.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start15 Jun 2017
- Primary completion30 Sep 2017
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic Disorder of SpineStudies 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
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959059
- Sponsor's protocol ID
- KY20160122-47
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 22 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei P, Yao Q, Xu Y, Zhang H, Gu Y, Wang L. Percutaneous kyphoplasty assisted with/without mixed reality technology in treatment of OVCF with IVC: a prospective study. J Orthop Surg Res. 2019 Aug 8;14(1):255. doi: 10.1186/s13018-019-1303-x.
PubMed 31395071
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
- ClinicalTrials.gov ID
- NCT03959059
- Acronym / sponsor ID
- KY20160122-47
- Conditions
- Orthopedic Disorder of Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 22 May 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.
To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.
Detailed description
The study is to prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and post-operation. The volume of injected cement and Operation time was recorded. And whether cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological evidence were also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PKP of traditional procedure | Experimental | Device: Mixed Reality technologytraditional method of PKP |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single level OVCF in the thoracic and lumbar levels (T10-L4), suffering with severe back pain.;
- OVCF without damaged vertebral posterior wall and nerve lesion;
- The patient was over 50 years old and , the diagnosis of osteopenia or osteoporosis was confirmed by bone densitometry ;
- All patients underwent（received） plain radiography, computed tomography (CT) and MRI before surgery, and with IVC presented in MRI.
Key exclusion criteria (1 listed)
- -
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 | PKP of traditional procedure |
Primary outcome
visual analog scale
Time frame: 1 year
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Oswestry Disability Index
Time frame: 1 year
Oswestry Disability Index is for movement function, Questionnaire examines perceived level of disability in everyday activities of daily living. The ODI score (index) is calculated as: For example: If all 10 sections are completed, the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%; If one section is missed (or not applicable), the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%.
Vertebral height
Time frame: 1 year
Vertebral height in X-ray is for recontruction of the vertebra.
Kyphotic angle
Time frame: 1 year
kyphotic angle in X-ray is also for recontruction of the vertebra.
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 22 May 2019.
- Derived from this study: PubMed 31395071Wei P, Yao Q, Xu Y, Zhang H, Gu Y, Wang L. Percutaneous kyphoplasty assisted with/without mixed reality technology in treatment of OVCF with IVC: a prospective study. J Orthop Surg Res. 2019 Aug 8;14(1):255. doi: 10.1186/s13018-019-1303-x.
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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 Orthopedic Disorder of Spine, 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 4 inclusion and 1 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 22 May 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: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959059, which also lists 1 linked publication.
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 22 May 2019.