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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00689923
• Other study ID #: 200710029R
• Secondary ID: 200710029R
• Status: Active, not recruiting
• Phase: N/A
• First received: June 1, 2008
• Last updated: June 3, 2008
• Start date: November 2007

Study information

• Verified date: May 2008
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

Description:

Pain relief; Comparatle

Cement Leakage; Comparacle

Irradiation dose：less

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• infection and malignancy in local region

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Compression Fracture
• Fractures, Compression
• Osteoporosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief		immediately after procedure	Yes
Secondary	cement leak		immediate after procedure	Yes