Study to Analyze the Effects of EBI OsteoGen™ on the Surg... | NCT00726193

Studies
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions

NCT00726193

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Jan 24, 2019Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Tibia Fracture Non Union Bone

Interventions

OsteoGen

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow enrollment, lack of follow up

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

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

Jan 22, 2019

Last Update Posted Date

Jan 24, 2019Actual

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 clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

Detailed Description

This clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 - standard films		Tibia reconstruction surgery with OsteoGen™ with standard radiographs	Device: OsteoGen
2 - Standard films plus CT		Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks.	Device: OsteoGen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OsteoGen	Device	OsteoGen Implatable stimulator	1 - standard films 2 - Standard films plus CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure for this trial will be the percentage of successful tibia unions achieved		8 Months

Secondary Outcomes

Measure	Description	Time Frame
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)		8 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of a tibia nonunion.
Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

Subject has open wounds or underlying osteomyelitis.
Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points.
If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
Subject has an implanted unipolar pacemaker.
Subject has active cancer.
Subject has severe peripheral vascular disease (ABI <0.4)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

private practice patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joel Batts	Biomet Spine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopedic Foot and Ankle Center		Columbus	Ohio	43231	United States

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