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Completed

NCT Number: NCT00994032

Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures

The purpose of this study is to determine whether percutaneous vertebroplasty is able to improve long-term quality of life in patients with pain secondary to osteoporotic vertebral fractures, compared to conventional medical treatment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic of Barcelona

Barcelona, Catalonia, 08036, Spain

About this study

Osteoporotic vertebral fractures are associated with pain and severe disability in a high percentage of patients. Vertebroplasty has become the treatment of choice to alleviate pain in those patients who have not responded to medical treatment.Although several case series and non-randomized studies have shown the effectiveness of vertebroplasty in alleviating pain secondary to osteoporotic vertebral fractures, the long-term effect of this treatment has not been compared to standard medical treatment in a randomized study.

In our study we have analyzed the long-term effect of vertebroplasty in terms of quality of life in patients with painful osteoporotic vertebral fractures, randomizing them into two arms: percutaneous vertebroplasty or conventional medical treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Painful (pain intensity of at least 4 on a scale from 0 to 10) osteoporotic vertebral fracture between levels T4 and L5
  • Fragility; i.e. fracture not in relation with significant trauma
  • Recent fracture, pain beginning not earlier than 1 year before inclusion

Exclusion criteria

  • No vertebral edema on STIR MR images
  • Uncorrectable bleeding diatheses
  • Active infection
  • Substantial retropulsion of bony fragments
  • Non-osteoporotic fracture
  • Concomitant neoplasm

Treatment and study plan

percutaneous injection of cement into the vertebral body

Procedure

percutaneous injection of cement into the vertebral body

Medical treatment

Other

standard antalgic medical treatment

Primary outcomes

  1. Impact into quality of life with the Qualeffo-41 test

    Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year

Secondary outcomes

  1. Analyze pain alleviation with the Analog Visual Scale

    Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Sociedad Española de Radiologia Medica

Registry information

Official study title

Analysis of the Impact in the Quality of Life of Patients With Pain Secondary to Osteoporotic Vertebral Fractures Receiving Conservative Treatment Versus Percutaneous Vertebroplasty

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
Feb 23, 2017

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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