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Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689923
First Posted: June 4, 2008
Last Update Posted: June 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.

Condition
Osteoporosis Compression Fracture

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • pain relief [ Time Frame: immediately after procedure ]

Secondary Outcome Measures:
  • cement leak [ Time Frame: immediate after procedure ]

Estimated Enrollment: 100
Study Start Date: November 2007
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Pain relief; Comparatle

Cement Leakage; Comparacle

Irradiation dose:less

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
painful vertebral compression fracture
Criteria

Inclusion Criteria:

  • all painful fracture that can not be relieved by pain killer.

Exclusion Criteria:

  • infection and malignancy in local region
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00689923     History of Changes
Other Study ID Numbers: 200710029R
First Submitted: June 1, 2008
First Posted: June 4, 2008
Last Update Posted: June 4, 2008
Last Verified: May 2008

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