Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures
Primary Purpose
Spinal Fracture, Osteoporosis, Back Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
percutaneous injection of cement into the vertebral body
Medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Fracture focused on measuring vertebroplasty, disability evaluation, outcome assessment, pain measurement
Eligibility Criteria
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
Sites / Locations
- Hospital Clinic of Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
vertebroplasty
Medical Treatment
Arm Description
Outcomes
Primary Outcome Measures
Impact into quality of life with the Qualeffo-41 test
Secondary Outcome Measures
Analyze pain alleviation with the Analog Visual Scale
Full Information
NCT ID
NCT00994032
First Posted
October 13, 2009
Last Updated
February 22, 2017
Sponsor
Hospital Clinic of Barcelona
Collaborators
Sociedad Española de Radiologia Medica
1. Study Identification
Unique Protocol Identification Number
NCT00994032
Brief Title
Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 1, 2011 (Actual)
Study Completion Date
June 1, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Sociedad Española de Radiologia Medica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fracture, Osteoporosis, Back Pain
Keywords
vertebroplasty, disability evaluation, outcome assessment, pain measurement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vertebroplasty
Arm Type
Active Comparator
Arm Title
Medical Treatment
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
percutaneous injection of cement into the vertebral body
Intervention Description
percutaneous injection of cement into the vertebral body
Intervention Type
Other
Intervention Name(s)
Medical treatment
Intervention Description
standard antalgic medical treatment
Primary Outcome Measure Information:
Title
Impact into quality of life with the Qualeffo-41 test
Time Frame
Baseline, 2 weeks, 2 months, 6 months and 1 year
Secondary Outcome Measure Information:
Title
Analyze pain alleviation with the Analog Visual Scale
Time Frame
Baseline, 2 weeks, 2 months, 6 months and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Blasco, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22513649
Citation
Blasco J, Martinez-Ferrer A, Macho J, San Roman L, Pomes J, Carrasco J, Monegal A, Guanabens N, Peris P. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012 May;27(5):1159-66. doi: 10.1002/jbmr.1564.
Results Reference
derived
Links:
URL
http://www.iofbonehealth.org/
Description
International Osteoporosis Foundation
Learn more about this trial
Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures
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