PKP Assisted With MR Technology in OVCF With IVC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2018-03-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Orthopedic Disorder of Spine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PKP of traditional procedure

traditional method of PKP

Group Type EXPERIMENTAL

Mixed Reality technology

Intervention Type DEVICE

combine image with real body

Interventions

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Mixed Reality technology

combine image with real body

Intervention Type DEVICE

Eligibility Criteria

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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.