Loading clinical trials...
Loading clinical trials...
Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
Yes
University of Arizona
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Orthopaedic Associates of South Broward, P.A.
Hollywood, Florida, United States
OrlandoHealth
Orlando, Florida, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Rutgers Biomedical Health Sciences
Newark, New Jersey, United States
University of Rochester
Rochester, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
Start Date
January 23, 2017
Primary Completion Date
March 1, 2022
Completion Date
June 1, 2022
Last Updated
March 21, 2022
217
ESTIMATED participants
Active Combined Magnetic Field OL1000 Bone Growth Stimulator
DEVICE
Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
DEVICE
Lead Sponsor
Encore Medical, L.P.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions