Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

Ullevaal University Hospital

Status: Suspended

Conditions: Osteoporosis; Vertebral Fracture

Treatments: Procedure: Percutaneous vertebroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00635297

889 VP

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous vertebroplasty

2

Experimental group

Description:

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

Treatment:

Procedure: Percutaneous vertebroplasty