A Observational Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fracture

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:
NCT00586170
First received: December 21, 2007
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th Metatarsal non-union Fractures.


Condition Intervention
5th Metatarsal Non Union Fracture
Device: EBI Bone Healing System

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Observational Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fracture: Effect on Clinical Outcome and Growth Factor Synthesis

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Percentage of successful 5th metatarsal unions achieved. [ Time Frame: 24 Weeks ] [ 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: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: November 2007
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 - EBI Bone Healing System + Surgery
Subject will be using the EBI Bone Healing System in conjunction with reconstructive ankle surgery.
Device: EBI Bone Healing System
10 hours of treatment per day for up to 24 weeks

Detailed Description:

The investigators hypothesize:

  1. That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures.
  2. PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th Metatarsal Non-union Fractures.
  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

Subjects who have been diagnosed with a 5th Metatarsal Non-Union for a minimum of three months.

Criteria

Inclusion Criteria:

  1. Subject has been diagnosed with a 5th metatarsal delayed or non-union.
  2. Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
  3. Male or female between ages of 18 and 75 years old, inclusive

Exclusion Criteria:

  1. Subject has synovial pseudarthrosis.
  2. Subject has a fracture gap of larger than 5mm as measured on CT Scan.
  3. Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
  4. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
  5. Subject has an implanted unipolar pacemaker.
  6. Subjects who have previous malignant or connective tissue disorder.
  7. Subjects who use medication such as steroids or anticoagulants.
  8. Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
  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: NCT00586170

Locations
United States, New Jersey
Neurological Institute of NJ
Newark, New Jersey, United States, 07103
United States, Ohio
The 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: Betsy Lowry, CCRP 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: NCT00586170     History of Changes
Other Study ID Numbers: CS-027
Study First Received: December 21, 2007
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
non union
fracture

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

ClinicalTrials.gov processed this record on September 30, 2014