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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

Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE June 15, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PKP Assisted With MR Technology in OVCF With IVC
Official Title  ICMJE Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Orthopedic Disorder of Spine
Intervention  ICMJE Device: Mixed Reality technology
combine image with real body
Study Arms  ICMJE Experimental: PKP of traditional procedure
traditional method of PKP
Intervention: Device: Mixed Reality technology
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 20, 2018
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959059
Other Study ID Numbers  ICMJE KY20160122-47
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanjing First Hospital, Nanjing Medical University
Study Sponsor  ICMJE Nanjing First Hospital, Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nanjing First Hospital, Nanjing Medical University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP