MedPath

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

Completed
Conditions
Spinal Stenosis
Degenerative Disc Disease
Registration Number
NCT00726284
Lead Sponsor
Zimmer Biomet
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
651
Inclusion Criteria

N/A

Exclusion Criteria

N/A

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fusion Status24 Months

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

Secondary Outcome Measures
NameTimeMethod
Mean VAS (Visual Analog Scale) Score Change from baseline24 Month
Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline24 Month
neurologic Assessment - maintenance or Improvement24 Month
SF-36 (Short Form Survey-36) Health Outcomes - Change from Baseline24 Month

Trial Locations

Locations (5)

Neurological Surgery Associates

🇺🇸

Little Rock, Arkansas, United States

Florida Orthopedics Association

🇺🇸

Orange City, Florida, United States

CNS Healthcare

🇺🇸

Akron, Ohio, United States

Oklahoma Spine and Brain

🇺🇸

Tulsa, Oklahoma, United States

Pottstown Memorial Medical Center

🇺🇸

Pottstown, Pennsylvania, United States

© Copyright 2025. All Rights Reserved by MedPath