A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures
Stopped early · Not applicable · Has a placebo group
Conditions studied: Nonunion of Fracture of Fifth Metatarsal
In brief
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
Key facts
- Study ID
- NCT00586170
- Run by
- Zimmer Biomet
- People needed
- 8
- Starts
- 2007-11-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2017-06-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Neurological Institute of NJ — Newark, New Jersey, United States
- The Orthopedic Foot and Ankle Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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