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Completed

NCT Number: NCT00279877

Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

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

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Key information

Conditions

Osteoporotic Vertebral Compression Fractures

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • > or = 50 years of age
  • Compression fracture (T4-L5)within previous 12 mo.
  • Pain from compression fracture
  • No malignant tumor
  • No back surgery

Treatment and study plan

Kyphoplasty

Procedure

kyphoplasty

Primary outcomes

  1. Back specific functional status(Roland)

    Time frame: 12 mo

  2. Pain

    Time frame: 12 mo

Secondary outcomes

  1. Health status outcome measure(SF-36)

    Time frame: 12 mo

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • ArthroCare Corporation
  • Cardinal Health
  • Cook Group Incorporated

Registry information

Official study title

Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2006
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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