We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Spine Patient Outcomes Registry for Biomet/EBI (SPO)

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.
ClinicalTrials.gov Identifier: NCT00726284
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Degenerative Disc Disease Spinal Stenosis

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

Study Design

Study Type : Observational
Actual Enrollment : 651 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIOMET/EBI Spine Patient Outcomes Registry
Study Start Date : April 2004
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Percentage of successful radiographic fusions achieved [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Mean VAS Score Change from baseline [ Time Frame: 24 Month ]
  2. Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline [ Time Frame: 24 Month ]
  3. neurologic Assessment - maintenance or Improvement [ Time Frame: 24 Month ]
  4. SF-36 Health Outcomes - Change from Baseline [ Time Frame: 24 Month ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is an open cohort prospective patient registry conducted at multiple clinical centers
Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726284


Locations
United States, Arkansas
Neurological Surgery Associates
Little Rock, Arkansas, United States, 72205
United States, Florida
Florida Orthopedics Association
Orange City, Florida, United States, 32763
United States, Ohio
CNS Healthcare
Akron, Ohio, United States, 44333
United States, Oklahoma
Oklahoma Spine and Brain
Tulsa, Oklahoma, United States, 74132
United States, Pennsylvania
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00726284     History of Changes
Other Study ID Numbers: CS-006
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: February 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
HNP

Additional relevant MeSH terms:
Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases