NCT00726193

Terminated

Study to Analyze the Effects of EBI OsteoGen™ on the Surgica...

Zimmer Biomet Source

Zimmer Biomet

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CS-012

Study Type

observational

Actual enrollment (reported)

4

Locations

1 country

Sites

1

Timeline

Study Start

June 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2008

Actual (reported)

Study Completion

April 2008

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 4 participants
Study completion date: April 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2006
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)
Study Completion
April 2008
Actual (reported)
First Submitted
July 29, 2008
Actual (reported)
First Posted
July 31, 2008
Actual (reported)

Last Updated: January 24, 2019
Status Verified: January 2019
Last Update Submitted: January 22, 2019

Conditions

Tibia Fracture Non Union Bone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (2)

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

OsteoGenDevice

OsteoGen Implatable stimulator

1 - standard films2 - Standard films plus CT

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

private practice patients

You may qualify if:

Diagnosis of a tibia nonunion.

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

Orthopedic Foot and Ankle Center

Columbus, Ohio, 43231, United States

Study Officials

Joel Batts
Biomet Spine
STUDY DIRECTOR

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

June 2006

Date type not reported

This date has not been verified as actual or estimated.

Male or female between ages of 18 and 75 years old, inclusive

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Primary Completion

April 2008

Actual (reported)

Study Completion

April 2008

Actual (reported)

Last Updated

January 24, 2019

Record last verified: 2019-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00726193
Data provider: ClinicalTrials.gov
Source updated: 2019-01-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:57 UTC

Locations

US(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1 - standard films

2 - Standard films plus CT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1 - standard films

2 - Standard films plus CT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations