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NCT00279877 Clinical Trial

Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

Osteoporotic Vertebral Compression Fractures Clinical Trial

Official title:
Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00279877
Other study ID # 12031
Secondary ID
Status Completed
Phase Phase 3
First received January 18, 2006
Last updated August 17, 2016
Start date May 2005
Est. completion date September 2011

Study information
Verified date August 2016
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 100 Years
Eligibility - > or = 50 years of age

- Compression fracture (T4-L5)within previous 12 mo.

- Pain from compression fracture

- No malignant tumor

- No back surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Kyphoplasty
kyphoplasty

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (4)
Lead Sponsor Collaborator
University of Virginia ArthroCare Corporation, Cardinal, Cook

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Back specific functional status(Roland) 12 mo No
Primary Pain 12 mo No
Secondary Health status outcome measure(SF-36) 12 mo No
See also
  Status Clinical Trial Phase
Completed NCT01482793 - A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures N/A
Recruiting NCT01609712 - Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation N/A
Recruiting NCT05337696 - Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant N/A
Recruiting NCT06261242 - Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment N/A
Recruiting NCT06270173 - Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures N/A
Active, not recruiting NCT04795765 - SpineJack System Postmarket Registry