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KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures

NCT00323609 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2018-01-02

Study results available
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Summary

Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain, back function, quality of life, adverse events, subsequent fractures and cumulative healthcare costs will be compared.

Conditions

  • Vertebral Body Compression Fractures

Interventions

PROCEDURE

Vertebroplasty

Vertebroplasty involves placement of a needle into the vertebral body. Cement is injected into the vertebral body.

PROCEDURE

Kyphoplasty

Balloon Kyphoplasty involves two inflatable bone tamps placed into the vertebral body in the spine. After the tamps are removed, the void is filled with viscous bone cement.

Sponsors & Collaborators

  • Medtronic Spine LLC

    lead INDUSTRY

Principal Investigators

  • Reginald Knight, MD · Orthopedics International

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323609 on ClinicalTrials.gov