Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635297

Enrollment

100

Registered

2008-03-13

Start date

2008-04-30

Completion date

2009-04-30

Last updated

2010-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Vertebral Fracture

Keywords

osteoporosis, vertebroplasty, prophylactic, vertebrae, fracture

Brief summary

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.

Interventions

PROCEDUREPercutaneous vertebroplasty

PMMA injection 3-10 milliliter in each treated vertebrae

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Refracture rate based on MRI and CT after 3 months and one year	3 months and one year

Secondary

Measure	Time frame
Pain relief after the procedure based on VAS	3 months and one year

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026