Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203554
• Other study ID #: 20020306
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: March 26, 2008
• Start date: March 2004
• Est. completion date: January 2008

Study information

• Verified date: March 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture
• Osteoporosis
• Pain

Intervention

Genetic:
• Poly methylmetacrylate, PMMA

Locations

Country	Name	City	State
Denmark	Dep of Neuroradiology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of pain		before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.	Yes
Secondary	Needs for analgetics, number of days at hospital, level of ADL		before treatment and day 1, day 3, day 10 and after 1, 3, 6 and 12 months.	Yes