NCT00726284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
651

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3.7 years

First QC Date

July 29, 2008

Last Update Submit

February 20, 2020

Conditions

Degenerative Disc DiseaseSpinal Stenosis

Keywords

Herniated nucleus pulposus (HNP)

Outcome Measures

Primary Outcomes (1)

  • Fusion Status

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

    24 Months

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • N/A

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Neurological Surgery Associates

Little Rock, Arkansas, 72205, United States

Location

Florida Orthopedics Association

Orange City, Florida, 32763, United States

Location

CNS Healthcare

Akron, Ohio, 44333, United States

Location

Oklahoma Spine and Brain

Tulsa, Oklahoma, 74132, United States

Location

Pottstown Memorial Medical Center

Pottstown, Pennsylvania, 19464, United States

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • John Evangelsita, MD

    EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

April 1, 2004

Primary Completion

December 6, 2007

Study Completion

December 6, 2007

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations

US(5)