CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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