BIOMET/EBI (Electro-Biology, Inc) Spine Patient Outcomes Registry

Zimmer Biomet5 sites in 1 country651 target enrollmentApril 2004

ConditionsDegenerative Disc Disease Spinal Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: Zimmer Biomet
Enrollment: 651
Locations: 5
Primary Endpoint: Fusion Status
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.

Detailed Description

A patient registry to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

December 6, 2007

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Fusion Status

Time Frame: 24 Months

The primary outcome measure for this trial will be the percentage of successful fusions achieved.

Secondary Outcomes

Mean VAS (Visual Analog Scale) Score Change from baseline(24 Month)
Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline(24 Month)
neurologic Assessment - maintenance or Improvement(24 Month)
SF-36 (Short Form Survey-36) Health Outcomes - Change from Baseline(24 Month)