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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00726284

Acronym

SPO

Enrollment

651

Registered

2008-07-31

Start date

2004-04-30

Completion date

2007-12-06

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease, Spinal Stenosis

Keywords

Herniated nucleus pulposus (HNP)

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

N/A

Exclusion criteria

N/A

Design outcomes

Primary

Measure	Time frame	Description
Fusion Status	24 Months	The primary outcome measure for this trial will be the percentage of successful fusions achieved.

Secondary

Measure	Time frame
Mean VAS (Visual Analog Scale) Score Change from baseline	24 Month
Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline	24 Month
neurologic Assessment - maintenance or Improvement	24 Month
SF-36 (Short Form Survey-36) Health Outcomes - Change from Baseline	24 Month

Countries

United States

Outcome results