Spine Patient Outcomes Registry for Biomet/EBI (Electro-B... | NCT00726284

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

NCT00726284

Sponsor

Zimmer Biomet

Status

Completed

Last Update Posted

Feb 24, 2020Actual

Enrollment

651Actual

Phase

Not provided

Conditions

Degenerative Disc Disease
Spinal Stenosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Dec 6, 2007Actual

Completion Date

Dec 6, 2007Actual

First Submitted Date

Jul 29, 2008

First Submission Date that Met QC Criteria

Jul 30, 2008

First Posted Date

Jul 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2020

Last Update Posted Date

Feb 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

651Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

N/A

Exclusion Criteria:

N/A

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Evangelsita, MD	EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurological Surgery Associates		Little Rock	Arkansas	72205	United States
Florida Orthopedics Association

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055959	Intervertebral Disc Degeneration
D013130	Spinal Stenosis

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided