Back to resultsPercutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra
Primary Purpose
Osteoporosis, Vertebral Fracture
Status
Suspended
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Percutaneous vertebroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, vertebroplasty, prophylactic, vertebrae, fracture
Eligibility Criteria
Inclusion Criteria:
- CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.
Exclusion Criteria:
- Infection
- High grade spinal stenosis
- Contraindications to MRI
- Dementia
Sites / Locations
- Nevroradiologisk avdeling Ullevål universitetssykehus HF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty
50 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
Outcomes
Primary Outcome Measures
Refracture rate based on MRI and CT after 3 months and one year
Secondary Outcome Measures
Pain relief after the procedure based on VAS
Full Information
NCT ID
NCT00635297
First Posted
March 5, 2008
Last Updated
March 2, 2010
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00635297
Brief Title
Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra
Official Title
Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Suspended
Why Stopped
Problems with patient recruitement
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Vertebral Fracture
Keywords
osteoporosis, vertebroplasty, prophylactic, vertebrae, fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty
Arm Title
2
Arm Type
Experimental
Arm Description
50 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
Intervention Type
Procedure
Intervention Name(s)
Percutaneous vertebroplasty
Other Intervention Name(s)
PMMA
Intervention Description
PMMA injection 3-10 milliliter in each treated vertebrae
Primary Outcome Measure Information:
Title
Refracture rate based on MRI and CT after 3 months and one year
Time Frame
3 months and one year
Secondary Outcome Measure Information:
Title
Pain relief after the procedure based on VAS
Time Frame
3 months and one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.
Exclusion Criteria:
Infection
High grade spinal stenosis
Contraindications to MRI
Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Hj Nakstad, Phd
Organizational Affiliation
Nevroradiologisk avdeling Ullevål Universitetssykehus HF
Official's Role
Study Director
Facility Information:
Facility Name
Nevroradiologisk avdeling Ullevål universitetssykehus HF
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra
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