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

Not Applicable

Completed

• Conditions: Spinal Fracture; Osteoporosis; Back Pain
• Interventions: Other: Medical treatment; Procedure: percutaneous injection of cement into the vertebral body

• Registration Number: NCT00994032
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2011-06-01
• Study Completion: 2011-06-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Treatment	Medical treatment	-
vertebroplasty	percutaneous injection of cement into the vertebral body	-

Primary Outcome Measures

Name	Time	Method
Impact into quality of life with the Qualeffo-41 test	Baseline, 2 weeks, 2 months, 6 months and 1 year

Secondary Outcome Measures

Name	Time	Method
Analyze pain alleviation with the Analog Visual Scale	Baseline, 2 weeks, 2 months, 6 months and 1 year

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Catalunya, Spain