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Completed

NCT Number: NCT00203554

Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

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.

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Key information

Conditions

Pain Bone Diseases Bone Diseases, Metabolic Fracture Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoporosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep of Neuroradiology, Aarhus University Hospital

Aarhus, DK 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Poly methylmetacrylate, PMMA

Genetic

Primary outcomes

  1. Level of pain

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Mar 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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