Spine Patient Outcomes Registry (SPO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier:
NCT00726284
First received: July 29, 2008
Last updated: February 13, 2012
Last verified: February 2012

July 29, 2008
February 13, 2012
April 2004
July 2009   (final data collection date for primary outcome measure)
Percentage of successful radiographic fusions achieved [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726284 on ClinicalTrials.gov Archive Site
  • Mean VAS Score Change from baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
  • Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
  • neurologic Assessment - maintenance or Improvement [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
  • SF-36 Health Outcomes - Change from Baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Spine Patient Outcomes Registry
BIOMET/EBI Spine Patient Outcomes Registry

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

This is an open cohort prospective patient registry conducted at multiple clinical centers

  • Degenerative Disc Disease
  • Spinal Stenosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
651
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

N/A

Exclusion Criteria:

N/A

Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00726284
CS-006
No
Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Not Provided
Study Director: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Biomet, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP