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Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

Primary Purpose

Pain, Osteoporosis, Fracture

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Poly methylmetacrylate, PMMA

About this trial

This is an interventional treatment trial for Pain focused on measuring osteoporosis, vertebra, fracture, pain, percutaneous, vertebroplasty, polymethylmetacrylate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dep of Neuroradiology, Aarhus University Hospital

Outcomes

Primary Outcome Measures

Level of pain

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00203554

First Posted

September 16, 2005

Last Updated

March 26, 2008

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT00203554

Brief Title

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

Official Title

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain: A Prospective, Randomized Controlled Study of Osteoporotic Fractures in the Spine

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Aarhus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Osteoporosis, Fracture

Keywords

osteoporosis, vertebra, fracture, pain, percutaneous, vertebroplasty, polymethylmetacrylate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

Poly methylmetacrylate, PMMA

Primary Outcome Measure Information:

Title

Level of pain

Time Frame

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

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leif Sorensen, Consultant

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dep of Neuroradiology, Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

DK 8000

Country

Denmark

12. IPD Sharing Statement

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Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

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