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

Tibia Fracture Non Union Bone Clinical Trial

Official title:

A Prospective Randomized Multi - Center Clinical Outcomes Collection Study To Analyze The Effect Of Ebi Osteogen™ Direct Current Stimulator On The Surgical Reconstruction Of Tibia Nonunions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00726193
• Other study ID #: CS-012
• Status: Terminated
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: January 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Ununited
• Tibia Fracture Non Union Bone
• Tibial Fractures

Intervention

Device:
• OsteoGen
OsteoGen Implatable stimulator

Locations

Country	Name	City	State
United States	Orthopedic Foot and Ankle Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure for this trial will be the percentage of successful tibia unions achieved		8 Months
Secondary	Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)		8 Months