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Spine Patient Outcomes Registry for Biomet/EBI (SPO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00726284
First Posted: July 31, 2008
Last Update Posted: March 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
July 29, 2008
July 31, 2008
March 15, 2016
April 2004
July 2009   (Final data collection date for primary outcome measure)
Percentage of successful radiographic fusions achieved [ Time Frame: 24 Months ]
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 ]
  • Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline [ Time Frame: 24 Month ]
  • neurologic Assessment - maintenance or Improvement [ Time Frame: 24 Month ]
  • SF-36 Health Outcomes - Change from Baseline [ Time Frame: 24 Month ]
Same as current
Not Provided
Not Provided
 
Spine Patient Outcomes Registry for Biomet/EBI
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.
A patient registry to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
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:

Exclusion Criteria:

Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00726284
CS-006
No
Not Provided
Plan to Share IPD: Undecided
Zimmer Biomet
Zimmer Biomet
Not Provided
Study Director: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Zimmer Biomet
February 2012