“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.
Device - Active Combined Magnetic Field OL1000 Bone Growth Stimulator
Active CMF OL1000 Device
Device - Sham Combined Magnetic Field OL1000 Bone Growth Stimulator
Sham CMF OL1000
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