Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
- 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
- Diagnosis of a tibia nonunion.
- Male or female between ages of 18 and 75 years old, inclusive
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 - standard films OsteoGen Tibia reconstruction surgery with OsteoGen™ with standard radiographs 2 - Standard films plus CT OsteoGen Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks.
- Primary Outcome Measures
Name Time Method The primary outcome measure for this trial will be the percentage of successful tibia unions achieved 8 Months
- Secondary Outcome Measures
Name Time Method 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