CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Bimalleolar Ankle Fractures
In brief
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.
Key facts
- Study ID
- NCT02688855
- Run by
- Encore Medical, L.P.
- People needed
- 217
- Starts
- 2017-01-23
- Expected to finish
- 2022-06-01
- Last updated by the study team
- 2022-03-21
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject is diagnosed with an unstable, closed, isolated fracture of the ankle and underwent operative stabilization with plate(s) and/or screws (Weber Ankle Fracture Classification B and C)
You may not qualify if…
- Subject has an open fracture
- Subject has any additional fractures of another bone besides the ankle fracture that is to be treated in the study including the contralateral ankle
- Surgical stabilization was definitively performed with an external fixation system
- Surgical stabilization was performed in such a manner that it will result in a fusion of the ankle joint
- Malreduced Ankle as described by Phillips, et al 1985 JBJS
- Surgical procedure included the use of osteoinductive materials in addition to rigid fixation
- BMI ≥ 40 kg/m2
Where it is running
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Orthopaedic Associates of South Broward, P.A. — Hollywood, Florida, United States (enrolling)
- University of Arizona — Tucson, Arizona, United States (enrolling)
- William Beaumont Hospital — Royal Oak, Michigan, United States (enrolling)
- Rutgers Biomedical Health Sciences — Newark, New Jersey, United States (enrolling)
- University of Rochester — Rochester, New York, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- OrlandoHealth — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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