PKP Assisted With MR Technology in OVCF With IVC

Nanjing First Hospital, Nanjing Medical University40 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Orthopedic Disorder of Spine

Interventions

Mixed Reality technologyDEVICE

combine image with real body

Eligibility

Sex: ALLMin age: 50 YearsMax age: 95 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Mixed Reality

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

visual analog scale

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

Time frame: 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%.

Time frame: 1 year

Vertebral height

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

Time frame: 1 year

Kyphotic angle

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

Time frame: 1 year

Data from ClinicalTrials.gov

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