NCT03959059

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

May 10, 2019

Last Update Submit

May 21, 2019

Conditions

Orthopedic Disorder of Spine

Outcome Measures

Primary Outcomes (4)

  • visual analog scale

    visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.

    1 year

  • 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

  • Vertebral height

    Vertebral height in X-ray is for recontruction of the vertebra.

    1 year

  • Kyphotic angle

    kyphotic angle in X-ray is also for recontruction of the vertebra.

    1 year

Study Arms (1)

PKP of traditional procedure

EXPERIMENTAL

traditional method of PKP

Device: Mixed Reality technology

Interventions

Mixed Reality technologyDEVICE

combine image with real body

PKP of traditional procedure

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mixed Reality

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

  • 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.

    PMID: 31395071DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 22, 2019

Study Start

June 15, 2017

Primary Completion

September 30, 2017

Study Completion

March 20, 2018

Last Updated

May 22, 2019

Record last verified: 2019-05

Locations

CN(1)