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

Zimmer Biomet

Status: Terminated

Conditions: Tibia Fracture Non Union Bone

Treatments: Device: OsteoGen

Study type: Observational

Funder types: Industry

Identifiers

NCT00726193

CS-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

4 participants in 2 patient groups

1 - standard films

Description:

Tibia reconstruction surgery with OsteoGen™ with standard radiographs

Treatment:

Device: OsteoGen

2 - Standard films plus CT

Description:

Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks.

Treatment:

Device: OsteoGen