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Completed

NCT Number: NCT03959059

PKP Assisted With MR Technology in OVCF With IVC

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

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Key information

Conditions

Orthopedic Disorder of Spine

Age range

50 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mixed Reality

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Mixed Reality technology

Device

combine image with real body

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 22, 2019
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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