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

February 20, 2020 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

651

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Neurological Surgery Associates
    • Florida
      • Orange City, Florida, United States, 32763
        • Florida Orthopedics Association
    • Ohio
      • Akron, Ohio, United States, 44333
        • CNS Healthcare
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74132
        • Oklahoma Spine and Brain
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Memorial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is an open cohort prospective patient registry conducted at multiple clinical centers

Description

Inclusion Criteria:

N/A

Exclusion Criteria:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: John Evangelsita, MD, EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

December 6, 2007

Study Completion (Actual)

December 6, 2007

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (Estimate)

July 31, 2008

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Degenerative Disc Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe