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

Zimmer Biomet4 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Tibia Fracture Non Union Bone

Interventions

OsteoGenDEVICE

OsteoGen Implatable stimulator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Orthopedic Foot and Ankle Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

The primary outcome measure for this trial will be the percentage of successful tibia unions achieved

Time frame: 8 Months

Secondary Outcomes

Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)

Time frame: 8 Months

Data from ClinicalTrials.gov

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