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NCT00726284 Clinical Trial

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

Degenerative Disc Disease Clinical Trial

— SPO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00726284
Other study ID # CS-006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2004
Est. completion date December 6, 2007

Study information
Verified date February 2020
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 651
Est. completion date December 6, 2007
Est. primary completion date December 6, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

N/A

Exclusion Criteria:

N/A

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States CNS Healthcare Akron Ohio
United States Neurological Surgery Associates Little Rock Arkansas
United States Florida Orthopedics Association Orange City Florida
United States Pottstown Memorial Medical Center Pottstown Pennsylvania
United States Oklahoma Spine and Brain Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fusion Status The primary outcome measure for this trial will be the percentage of successful fusions achieved. 24 Months
Secondary Mean VAS (Visual Analog Scale) Score Change from baseline 24 Month
Secondary Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline 24 Month
Secondary neurologic Assessment - maintenance or Improvement 24 Month
Secondary SF-36 (Short Form Survey-36) Health Outcomes - Change from Baseline 24 Month
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