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Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty

NCT00810043 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-12-08

Study results available
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Summary

The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.

Conditions

  • Vertebral Body Compression Fractures (VCFs)

Interventions

DEVICE

Kyphon® Curette

The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures

Sponsors & Collaborators

  • Medtronic Spine LLC

    lead INDUSTRY

Principal Investigators

  • George Fueredi, M.D. · Aurora Heath Care, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • Belgium
  • Germany

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 NCT00810043 on ClinicalTrials.gov