Orthopedic Disorder of Spine Clinical Trial
Official title:
Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
Verified date | May 2019 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 20, 2018 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 95 Years |
Eligibility |
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: - |
Country | Name | City | State |
---|---|---|---|
China | Mixed Reality | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | visual analog scale | visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain. | 1 year | |
Primary | 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 | |
Primary | Vertebral height | Vertebral height in X-ray is for recontruction of the vertebra. | 1 year | |
Primary | Kyphotic angle | kyphotic angle in X-ray is also for recontruction of the vertebra. | 1 year |
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