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Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection
This study is ongoing, but not recruiting participants.
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00689923
  Purpose

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


Condition
Osteoporosis
Compression Fracture

MedlinePlus related topics: Fractures Osteoporosis
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cement leak [ Time Frame: immediate after procedure ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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 ( National Taiwan University Hospital )
Study ID Numbers: 200710029R, 200710029R
Study First Received: June 1, 2008
Last Updated: June 3, 2008
ClinicalTrials.gov Identifier: NCT00689923  
Health Authority: Taiwan: Department of Health

Study placed in the following topic categories:
Fractures, Compression
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
 Disorders of Environmental Origin
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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