The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization. The initiation of the adjunctive treatment is to begin within 11 days of surgical stabilization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
217
Active CMF OL1000 Device
Sham CMF OL1000
University of Arizona
Tucson, Arizona, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGChange overtime of Olerud and Molander Ankle Score (OMAS)
Time frame: 6 weeks, 8 weeks, 10 weeks and 12 weeks
Non-powered, composite safety endpoint consisting of: Joint Position Outcome Radiographic Failure and Repeat, Unplanned Surgery at the Operative Site and Device-Related Serious Adverse Events
Time frame: 6 months & 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orthopaedic Associates of South Broward, P.A.
Hollywood, Florida, United States
OrlandoHealth
Orlando, Florida, United States
WITHDRAWNWilliam Beaumont Hospital
Royal Oak, Michigan, United States
RECRUITINGRutgers Biomedical Health Sciences
Newark, New Jersey, United States
RECRUITINGUniversity of Rochester
Rochester, New York, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITING