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
  Purpose

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
Degenerative Disc Disease
Spinal Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIOMET/EBI Spine Patient Outcomes Registry

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Percentage of successful radiographic fusions achieved [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 651
Study Start Date: April 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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:

N/A

Exclusion Criteria:

N/A

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Investigators
Study Director: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier: NCT00726284     History of Changes
Other Study ID Numbers: CS-006
Study First Received: July 29, 2008
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
HNP

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

ClinicalTrials.gov processed this record on July 10, 2014