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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
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

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

Condition or disease Intervention/treatment Phase
Orthopedic Disorder of Spine Device: Mixed Reality technology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: PKP of traditional procedure
traditional method of PKP
Device: Mixed Reality technology
combine image with real body




Primary Outcome Measures :
  1. 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.

  2. 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%.

  3. Vertebral height [ Time Frame: 1 year ]
    Vertebral height in X-ray is for recontruction of the vertebra.

  4. Kyphotic angle [ Time Frame: 1 year ]
    kyphotic angle in X-ray is also for recontruction of the vertebra.



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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

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


Locations
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China, Jiangsu
Mixed Reality
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03959059     History of Changes
Other Study ID Numbers: KY20160122-47
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Diseases
Musculoskeletal Diseases
Bone Diseases