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A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00586170
First received: December 21, 2007
Last updated: April 11, 2016
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
Nonunion of Fracture of Fifth Metatarsal
Device: EBI Bone Healing System
Device: Placebo Device
Procedure: Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: 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 ]
    Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.


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: 8
Study Start Date: November 2007
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBI Bone Healing System + Surgery
Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Device: EBI Bone Healing System
10 hours of treatment per day for up to 24 weeks
Procedure: Surgery
Open Reduction and Internal Fixation of the nonunion site
Placebo Comparator: Placebo Device + Surgery
Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Device: Placebo Device
10 hours of treatment per day for up to 24 weeks
Procedure: Surgery
Open Reduction and Internal Fixation of the nonunion site

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Biomet, Inc.
Investigators
Study Director: John Evangelista Biomet, Inc.
  More Information

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00586170     History of Changes
Other Study ID Numbers: CS-027 
Study First Received: December 21, 2007
Results First Received: March 9, 2016
Last Updated: April 11, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Biomet, Inc.:
nonunion
fracture

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

ClinicalTrials.gov processed this record on December 06, 2016