Status:
COMPLETED
VERTOS-II. Percutaneous Vertebroplasty Versus Conservative Therapy
Lead Sponsor:
Clinical Research Office Imaging Division
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Osteoporosis
Back Pain
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 Nether...
Detailed Description
Design: This will be a multicenter (6 centers), prospective, randomized, intervention study. Eligible patients will be randomized for percutaneous vertebroplasty or analgesics. Study population:Two ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age: 50 and older
- vertebral fracture: 15-85% height loss
- level: thoracic vertebral body 5 (Th 5) or lower
- osteopenia (T-score \< -1 SD)
- back pain for at least no longer than 6 weeks
- edema in the vertebrae on MR imaging
- Exclusion criteria:
- complete loss of vertebral body height
- fracture through or destruction of the posterior vertebral wall
- pressure of bone fragments on the spinal cord
- osteomyelitis or spondylodiscitis
- vertebral column neoplasms
- uncorrectable coagulation disorder
- medical conditions that would make the patient ineligible for emergency decompressive surgery should it be necessary to treat a complication of the procedure
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00232466
Start Date
February 1 2006
End Date
June 1 2010
Last Update
February 15 2018
Active Locations (6)
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1
AZ St. Lucas Ziekenhuis
Ghent, Belgium, 9000
2
Diakonessenhuis
Utrecht/Zeist/Doorn, Utrecht, Netherlands, 3508 TG
3
Albert Schweizer Ziekenhuis
Dordrecht, Netherlands, 3300 AK
4
Catharina-Ziekenhuis
Eindhoven, Netherlands, 5623 EJ