Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

N/ACompletedNCT00203554

University of Aarhus27 enrolled

Overview

The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.

In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics. The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis. Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Osteoporosis Fracture

Interventions

Poly methylmetacrylate, PMMAGENETIC

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * new pain in spine (within 6 months) * x-ray verified low energy spinal fracture(s) Exclusion Criteria: * less than 20% or more than 90% reduction of the vertebral height * lack of pain at fracture level * no need for continuous analgesic treatment * patient no able to communicate * general anaesthesia contraindicated * MRI not possible * coagulopathy (not adjustable) * spondylitis * discitis * spinal metastasis

Locations (1)

Dep of Neuroradiology, Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Level of pain

Time frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Secondary Outcomes

Needs for analgetics, number of days at hospital, level of ADL

Time frame: before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.

Data from ClinicalTrials.gov

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