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Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

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ClinicalTrials.gov Identifier: NCT00635297
Recruitment Status : Suspended (Problems with patient recruitement)
First Posted : March 13, 2008
Last Update Posted : March 3, 2010
Sponsor:
Information provided by:
Ullevaal University Hospital

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.


Condition or disease Intervention/treatment
Osteoporosis Vertebral Fracture Procedure: Percutaneous vertebroplasty

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae
Study Start Date : April 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty
Procedure: Percutaneous vertebroplasty
PMMA injection 3-10 milliliter in each treated vertebrae
Other Name: PMMA
Experimental: 2
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
Procedure: Percutaneous vertebroplasty
PMMA injection 3-10 milliliter in each treated vertebrae
Other Name: PMMA



Primary Outcome Measures :
  1. Refracture rate based on MRI and CT after 3 months and one year [ Time Frame: 3 months and one year ]

Secondary Outcome Measures :
  1. Pain relief after the procedure based on VAS [ Time Frame: 3 months and one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635297


Locations
Norway
Nevroradiologisk avdeling Ullevål universitetssykehus HF
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Per Hj Nakstad, Phd Nevroradiologisk avdeling Ullevål Universitetssykehus HF

Responsible Party: Øivind Gjertsen Md Nevroradiologisk avdeling Ullevål universitetssykehus HF, Ullevål universitetssykehus HF
ClinicalTrials.gov Identifier: NCT00635297     History of Changes
Other Study ID Numbers: 889 VP
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: January 2008

Keywords provided by Ullevaal University Hospital:
osteoporosis
vertebroplasty
prophylactic
vertebrae
fracture

Additional relevant MeSH terms:
Osteoporosis
Spinal Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone