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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. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier:
NCT00726193
First received: July 29, 2008
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  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
Non Union Tibia Fractures
 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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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
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
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Investigators
Study Chair: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier: NCT00726193     History of Changes
Other Study ID Numbers: CS-012
Study First Received: July 29, 2008
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013