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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00689923
First received: June 1, 2008
Last updated: June 3, 2008
Last verified: May 2008
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00689923     History of Changes
Other Study ID Numbers: 200710029R, 200710029R
Study First Received: June 1, 2008
Last Updated: June 3, 2008
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on June 17, 2013