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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-07-29
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-07-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

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

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