Back to resultsA Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
Primary Purpose
Nonunion of Fracture of Fifth Metatarsal
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EBI Bone Healing System
Placebo Device
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Nonunion of Fracture of Fifth Metatarsal focused on measuring nonunion, fracture
Eligibility Criteria
Inclusion Criteria:
- Subject has been diagnosed with a 5th metatarsal delayed or non-union.
- Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
- Male or female between ages of 18 and 75 years old, inclusive
Exclusion Criteria:
- Subject has synovial pseudarthrosis.
- Subject has a fracture gap of larger than 5mm as measured on CT Scan.
- Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
- If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
- Subject has an implanted unipolar pacemaker.
- Subjects who have previous malignant or connective tissue disorder.
- Subjects who use medication such as steroids or anticoagulants.
- Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
Sites / Locations
- Neurological Institute of NJ
- The Orthopedic Foot and Ankle Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EBI Bone Healing System + Surgery
Placebo Device + Surgery
Arm Description
Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Outcomes
Primary Outcome Measures
Percentage of Successful 5th Metatarsal Unions Achieved.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00586170
Brief Title
A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
Detailed Description
The investigators hypothesize:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonunion of Fracture of Fifth Metatarsal
Keywords
nonunion, fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EBI Bone Healing System + Surgery
Arm Type
Experimental
Arm Description
Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Arm Title
Placebo Device + Surgery
Arm Type
Placebo Comparator
Arm Description
Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Intervention Type
Device
Intervention Name(s)
EBI Bone Healing System
Intervention Description
10 hours of treatment per day for up to 24 weeks
Intervention Type
Device
Intervention Name(s)
Placebo Device
Intervention Description
10 hours of treatment per day for up to 24 weeks
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Open Reduction and Internal Fixation of the nonunion site
Primary Outcome Measure Information:
Title
Percentage of Successful 5th Metatarsal Unions Achieved.
Description
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.
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
Time Frame
24 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has been diagnosed with a 5th metatarsal delayed or non-union.
Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months.
Male or female between ages of 18 and 75 years old, inclusive
Exclusion Criteria:
Subject has synovial pseudarthrosis.
Subject has a fracture gap of larger than 5mm as measured on CT Scan.
Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma.
If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
Subject has an implanted unipolar pacemaker.
Subjects who have previous malignant or connective tissue disorder.
Subjects who use medication such as steroids or anticoagulants.
Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Evangelista
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Neurological Institute of NJ
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
The Orthopedic Foot and Ankle Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
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