An interventional study of percutaneous injection of cement into the vertebral body and Medical treatment in Spinal Fracture, Osteoporosis and Back Pain, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment
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.
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 120 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: percutaneous injection of cement into the vertebral body
Other: Medical treatment
percutaneous injection of cement into the vertebral body
standard antalgic medical treatment
Impact into quality of life with the Qualeffo-41 test
Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
Analyze pain alleviation with the Analog Visual Scale
Time frame: Baseline, 2 weeks, 2 months, 6 months and 1 year
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona