PKP Assisted With MR Technology in OVCF With IVC

Study Overview
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Brief Summary
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To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.

Detailed Description
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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.

Official Title
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Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study

Conditions
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Orthopedic Disorder of Spine

Intervention / Treatment
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* Device: Mixed Reality technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PKP of traditional procedure<br>traditional method of PKP | Device: Mixed Reality technology<br>* combine image with real body<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain. | 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%. | 1 year | 
| Vertebral height | Vertebral height in X-ray is for recontruction of the vertebra. | 1 year | 
| Kyphotic angle | kyphotic angle in X-ray is also for recontruction of the vertebra. | 1 year |