Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
NCT ID: NCT00726193
Last Updated: 2019-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
4 participants
OBSERVATIONAL
2006-06-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1 - standard films
Tibia reconstruction surgery with OsteoGen™ with standard radiographs
OsteoGen
OsteoGen Implatable stimulator
2 - Standard films plus CT
Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks.
OsteoGen
OsteoGen Implatable stimulator
Interventions
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OsteoGen
OsteoGen Implatable stimulator
Eligibility Criteria
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Inclusion Criteria
2. Male or female between ages of 18 and 75 years old, inclusive
Exclusion Criteria
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)
18 Years
75 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Batts
Role: STUDY_DIRECTOR
Biomet Spine
Locations
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Orthopedic Foot and Ankle Center
Columbus, Ohio, United States
Countries
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Other Identifiers
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CS-012
Identifier Type: -
Identifier Source: org_study_id
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