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PKP Assisted With MR Technology in OVCF With IVC

Primary Purpose

Orthopedic Disorder of Spine

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mixed Reality technology
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder of Spine

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Mixed Reality

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PKP of traditional procedure

Arm Description

traditional method of PKP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2019
Last Updated
May 21, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03959059
Brief Title
PKP Assisted With MR Technology in OVCF With IVC
Official Title
Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
March 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder of Spine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PKP of traditional procedure
Arm Type
Experimental
Arm Description
traditional method of PKP
Intervention Type
Device
Intervention Name(s)
Mixed Reality technology
Intervention Description
combine image with real body
Primary Outcome Measure Information:
Title
visual analog scale
Description
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Time Frame
1 year
Title
Oswestry Disability Index
Description
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%.
Time Frame
1 year
Title
Vertebral height
Description
Vertebral height in X-ray is for recontruction of the vertebra.
Time Frame
1 year
Title
Kyphotic angle
Description
kyphotic angle in X-ray is also for recontruction of the vertebra.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Facility Information:
Facility Name
Mixed Reality
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31395071
Citation
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.
Results Reference
derived

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PKP Assisted With MR Technology in OVCF With IVC

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