Study Stopped
Slow enrollment
A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
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
1 other identifier
interventional
8
1 country
2
Brief Summary
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
May 16, 2016
CompletedJune 21, 2017
June 1, 2017
3.8 years
December 21, 2007
March 9, 2016
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 Weeks
Secondary Outcomes (1)
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
24 Weeks
Study Arms (2)
EBI Bone Healing System + Surgery
EXPERIMENTALSubject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Placebo Device + Surgery
PLACEBO COMPARATORSubject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Interventions
10 hours of treatment per day for up to 24 weeks
Open Reduction and Internal Fixation of the nonunion site
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (2)
Neurological Institute of NJ
Newark, New Jersey, 07103, United States
The Orthopedic Foot and Ankle Center
Columbus, Ohio, 43231, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager of Research
- Organization
- Biomet
Study Officials
- STUDY DIRECTOR
John Evangelista
Zimmer Biomet
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 4, 2008
Study Start
November 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
June 21, 2017
Results First Posted
May 16, 2016
Record last verified: 2017-06