Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

NCT ID: NCT00635297

Last Updated: 2010-03-03

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

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.

The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.

Detailed Description

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Conditions

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Osteoporosis Vertebral Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty

Group Type ACTIVE_COMPARATOR

Percutaneous vertebroplasty

Intervention Type PROCEDURE

PMMA injection 3-10 milliliter in each treated vertebrae

2

50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty. The adjacent vertebrae will be treated with 3-5 ml of PMMA

Group Type EXPERIMENTAL

Percutaneous vertebroplasty

Intervention Type PROCEDURE

PMMA injection 3-10 milliliter in each treated vertebrae

Interventions

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Percutaneous vertebroplasty

PMMA injection 3-10 milliliter in each treated vertebrae

Intervention Type PROCEDURE

Other Intervention Names

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PMMA

Eligibility Criteria

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Inclusion Criteria

* CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.

Exclusion Criteria

* Infection
* High grade spinal stenosis
* Contraindications to MRI
* Dementia
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ullevål universitetssykehus HF

Principal Investigators

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Per Hj Nakstad, Phd

Role: STUDY_DIRECTOR

Nevroradiologisk avdeling Ullevål Universitetssykehus HF

Locations

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Nevroradiologisk avdeling Ullevål universitetssykehus HF

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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889 VP

Identifier Type: -

Identifier Source: org_study_id

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