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

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ClinicalTrials.gov Identifier: NCT00689923
Recruitment Status : Unknown
Verified May 2008 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2008
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.

Condition or disease
Osteoporosis Compression Fracture

Detailed Description:

Pain relief; Comparatle

Cement Leakage; Comparacle

Irradiation dose:less


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection
Study Start Date : November 2007
Estimated Primary Completion Date : October 2008



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

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


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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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00689923     History of Changes
Other Study ID Numbers: 200710029R
200710029R
First Posted: June 4, 2008    Key Record Dates
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