VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy
Recruitment status was: Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||VERTOS II. Percutaneous Vertebroplasty Versus Conservative Therapy in Patients With Osteoporotic Vertebral Fractures|
- To compare the cost-effectivity in the two groups [ Time Frame: 1 month, 1 year ] [ Designated as safety issue: No ]
- VAS score in time [ Time Frame: 1 month, 1 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: 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|