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Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

This study has suspended participant recruitment.
(Problems with patient recruitement)
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00635297
First received: March 5, 2008
Last updated: March 2, 2010
Last verified: January 2008
History of Changes
  Purpose

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 Intervention
Osteoporosis
Vertebral Fracture
 Procedure: Percutaneous vertebroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Refracture rate based on MRI and CT after 3 months and one year [ Time Frame: 3 months and one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain relief after the procedure based on VAS [ Time Frame: 3 months and one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 5, 2008
Last Updated: March 2, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on May 23, 2013