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

Terminated
Conditions
Tibia Fracture Non Union Bone
Interventions
Device: OsteoGen
Registration Number
NCT00726193
Lead Sponsor
Zimmer Biomet
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
4
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
1 - standard filmsOsteoGenTibia reconstruction surgery with OsteoGen™ with standard radiographs
2 - Standard films plus CTOsteoGenTibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks.
Primary Outcome Measures
NameTimeMethod
The primary outcome measure for this trial will be the percentage of successful tibia unions achieved8 Months
Secondary Outcome Measures
NameTimeMethod
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)8 Months

Trial Locations

Locations (1)

Orthopedic Foot and Ankle Center

🇺🇸

Columbus, Ohio, United States

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