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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Spinal Fracture, Osteoporosis, Back Pain

Intervention / Treatment
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* Procedure: percutaneous injection of cement into the vertebral body
* Other: Medical treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vertebroplasty<br> | Procedure: percutaneous injection of cement into the vertebral body<br>* percutaneous injection of cement into the vertebral body<br>|
| Active Comparator: Medical Treatment<br> | Other: Medical treatment<br>* standard antalgic medical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact into quality of life with the Qualeffo-41 test |  | Baseline, 2 weeks, 2 months, 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze pain alleviation with the Analog Visual Scale |  | Baseline, 2 weeks, 2 months, 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vertebroplasty, disability evaluation, outcome assessment, pain measurement