Status:
TERMINATED
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
Lead Sponsor:
Zimmer Biomet
Conditions:
Tibia Fracture Non Union Bone
Eligibility:
All Genders
18-75 years
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 si...
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)...
Eligibility Criteria
Inclusion
- Diagnosis of a tibia nonunion.
- Male or female between ages of 18 and 75 years old, inclusive
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00726193
Start Date
June 1 2006
End Date
April 1 2008
Last Update
January 24 2019
Active Locations (1)
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1
Orthopedic Foot and Ankle Center
Columbus, Ohio, United States, 43231