Study Stopped
Problems with patient recruitement
Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra
Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae
1 other identifier
interventional
100
1 country
1
Brief Summary
Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty. The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedMarch 3, 2010
January 1, 2008
1 year
March 5, 2008
March 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Refracture rate based on MRI and CT after 3 months and one year
3 months and one year
Secondary Outcomes (1)
Pain relief after the procedure based on VAS
3 months and one year
Study Arms (2)
1
ACTIVE COMPARATOR50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty
2
EXPERIMENTAL50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty. The adjacent vertebrae will be treated with 3-5 ml of PMMA
Interventions
PMMA injection 3-10 milliliter in each treated vertebrae
Eligibility Criteria
You may qualify if:
- CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.
You may not qualify if:
- Infection
- High grade spinal stenosis
- Contraindications to MRI
- Dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nevroradiologisk avdeling Ullevål universitetssykehus HF
Oslo, Oslo County, 0407, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Per Hj Nakstad, Phd
Nevroradiologisk avdeling Ullevål Universitetssykehus HF
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
March 3, 2010
Record last verified: 2008-01