Status:
COMPLETED
A Trial of Vertebroplasty for Painful Acute Osteoporotic Vertebral Fractures
Lead Sponsor:
Elisabeth-TweeSteden Ziekenhuis
Conditions:
Osteoporosis
Vertebral Fracture
Eligibility:
All Genders
50-95 years
Phase:
PHASE3
Brief Summary
The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), is a new minimally invasive technique for pain...
Detailed Description
Objectives To evaluate the efficacy of bone cement injection in PV for patients with acute painful osteoporotic compression fractures, as compared with a simulated placebo procedure without injection ...
Eligibility Criteria
Inclusion
- VCF on X-ray of the spine (minimal 15% loss of height)
- level of VCF Th5 or lower
- back pain ≤ 6 weeks at time of X-ray
- ≥ 50 years of age
- bone edema on MRI of the fractured vertebral body
- focal tenderness on VCF level
- decreased bone density T-scores ≤ -1
Exclusion
- severe cardio-pulmonary condition
- untreatable coagulopathy
- systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
- suspected alternative underlying disease (malignancy)
- radicular and/or cauda compression syndrome
- contra-indication for MRI
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01200277
Start Date
January 1 2011
End Date
January 1 2014
Last Update
November 18 2014
Active Locations (4)
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1
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3300AK
2
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623EJ
3
Medisch Spectrum Twente
Enschede, Netherlands, 7500KA
4
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022GC