VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy
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|ClinicalTrials.gov Identifier: NCT00232466|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : February 15, 2018
Percutaneous vertebroplasty is a new procedure for treating painful osteoporotic compression fractures of the spine. Five-thousand out of 12.000 patients (16.000 vertebral fractures/year in the Netherlands) present with sudden, severe back pain in the region of the fracture.Until recently, bed rest, analgesia and physical support were the only treatment options. After decades of performing PV, no large RCT with mid-term follow-up has been published.
This will be a multicenter (6 centers), prospective, randomised, intervention study. Eligible patients will be randomised for percutaneous vertebroplasty or conservative therapy.
Age: 50 and older, vertebral fracture, level: thoracic vertebral body 5 (Th 5) or lower, osteopenia (T-score < -1 SD), back pain for no more than 6 weeks and edema in the vertebrae on MR imaging
Statistical analyses All analyses will be performed on an 'intention to treat' principle. The planned number of subjects will be 200 in total, 100 in each intervention arm.
Cost-effectiveness will be assessed. The costs of the procedure and the medical treatment, and of visits to medical specialists, GP's and physical therapists will be compared.
The total study will take 36 months
Recruitment of patients (200) has been completed. In May 2009 the 1 year follow-up will be finished.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Back Pain||Procedure: Vertebroplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures|
|Study Start Date :||February 2006|
|Actual Study Completion Date :||June 2010|
No Intervention: 2
conservative therapy (no intervention)
Active Comparator: 1
The treatment consists of a transpedicular injection of polymethylmethacrylate bone cement into the collapsed vertebral body (maximal 2 vertebrae in 1 treatment session) using fluoroscopic guidance. The procedure is performed under the use of local anesthetics and the patient can be discharged the same day or after 1 night of hospital stay.
- To compare the cost-effectivity in the two groups [ Time Frame: 1 month, 1 year ]
- VAS score in time [ Time Frame: 1 month, 1 year ]
- To compare pain relief and the quality of life of the patients in the two groups. [ Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232466
|AZ St. Lucas Ziekenhuis|
|Gent, Belgium, 9000|
|Utrecht/Zeist/Doorn, Utrecht, Netherlands, 3508 TG|
|Albert Schweizer Ziekenhuis|
|Dordrecht, Netherlands, 3300 AK|
|Eindhoven, Netherlands, 5623 EJ|
|St. Elisabeth Ziekenhuis|
|Tilburg, Netherlands, 5022 GC|
|Utrecht, Netherlands, 3508 GA|
|Principal Investigator:||Willem Mali, MD.PhD||UMC Utrecht|