PKP Assisted With MR Technology in OVCF With IVC
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|ClinicalTrials.gov Identifier: NCT03959059|
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Orthopedic Disorder of Spine||Device: Mixed Reality technology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study|
|Actual Study Start Date :||June 15, 2017|
|Actual Primary Completion Date :||September 30, 2017|
|Actual Study Completion Date :||March 20, 2018|
Experimental: PKP of traditional procedure
traditional method of PKP
Device: Mixed Reality technology
combine image with real body
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959059
|Nanjing, Jiangsu, China, 210029|