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

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00726193
First received: July 29, 2008
Last updated: March 14, 2016
Last verified: May 2012
  Purpose
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.

Condition Intervention
Tibia Fracture Non Union Bone
Device: OsteoGen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • The primary outcome measure for this trial will be the percentage of successful tibia unions achieved [ Time Frame: 8 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline) [ Time Frame: 8 Months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 - standard films
Tibia reconstruction surgery with OsteoGen™ with standard radiographs
Device: OsteoGen
OsteoGen Implatable stimulator
2 - Standard films plus CT
Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks.
Device: OsteoGen
OsteoGen Implatable stimulator

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
private practice patients
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726193

Locations
United States, Ohio
Orthopedic Foot and Ankle Center
Columbus, Ohio, United States, 43231
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Joel Batts Biomet Spine
  More Information

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00726193     History of Changes
Other Study ID Numbers: CS-012 
Study First Received: July 29, 2008
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Tibial Fractures
Fractures, Ununited
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 29, 2016