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OpenTrials
Completed

NCT Number: NCT00726284

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

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.

Completed

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurological Surgery Associates, Little Rock, Arkansas, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

N/A

Exclusion criteria

N/A

Treatment and study plan

Primary outcomes

  1. Fusion Status

    Time frame: 24 Months

    The primary outcome measure for this trial will be the percentage of successful fusions achieved.

Secondary outcomes

  1. Mean VAS (Visual Analog Scale) 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 (Short Form Survey-36) Health Outcomes - Change from Baseline

    Time frame: 24 Month

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Acronym: SPO

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 31, 2008
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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