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

A Prospective Randomized Multi - Center Clinical Outcomes Collection Study To Analyze The Effect Of Ebi Osteogen™ Direct Current Stimulator On The Surgical Reconstruction Of Tibia Nonunions

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00726193

Enrollment

Registered

2008-07-31

Start date

2006-06-30

Completion date

2008-04-30

Last updated

2019-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibia Fracture Non Union Bone

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.

Interventions

DEVICEOsteoGen

OsteoGen Implatable stimulator

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of a tibia nonunion. 2. Male or female between ages of 18 and 75 years old, inclusive

Exclusion criteria

1. Subject has open wounds or underlying osteomyelitis. 2. Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points. 3. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating. 4. Subject has an implanted unipolar pacemaker. 5. Subject has active cancer. 6. Subject has severe peripheral vascular disease (ABI \<0.4)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026