TerminatedNot Applicable

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

Stopped: Slow enrollment

United States8 participantsStarted 2007-11

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Percentage of Successful 5th Metatarsal Unions Achieved.

Timeframe: 24 Weeks

NCT IDNCT00586170

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-08

Results submitted2016-03-09